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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95515

73 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 20, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
AVID Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

73 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 73

Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

Z-0383-2025
Recall number
Z-0383-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
80 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160304952 Lot Number: 1600756

Distribution pattern

US Nationwide distribution.

device · product 2 of 73

Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

Z-0384-2025
Recall number
Z-0384-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
24 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160304969 Lot Number: 1583034

Distribution pattern

US Nationwide distribution.

device · product 3 of 73

Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02

Z-0385-2025
Recall number
Z-0385-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160392027 Lot Number: 1596759

Distribution pattern

US Nationwide distribution.

device · product 4 of 73

Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

Z-0386-2025
Recall number
Z-0386-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
100 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160308288 Lot Number: 1591242, 1600320, 1604627

Distribution pattern

US Nationwide distribution.

device · product 5 of 73

Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

Z-0387-2025
Recall number
Z-0387-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
114 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160355725 Lot Number: 1597931

Distribution pattern

US Nationwide distribution.

device · product 6 of 73

Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02

Z-0388-2025
Recall number
Z-0388-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
36 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160355770 Lot Number: 1585536

Distribution pattern

US Nationwide distribution.

device · product 7 of 73

Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02

Z-0389-2025
Recall number
Z-0389-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
1,434 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160400111 Lot Number: 1583946

Distribution pattern

US Nationwide distribution.

device · product 8 of 73

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07

Z-0390-2025
Recall number
Z-0390-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
117 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160421857 Lot Number: 1606092

Distribution pattern

US Nationwide distribution.

device · product 9 of 73

Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06

Z-0391-2025
Recall number
Z-0391-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
42 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160423226 Lot Number: 1610214

Distribution pattern

US Nationwide distribution.

device · product 10 of 73

Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03

Z-0392-2025
Recall number
Z-0392-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
46 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160406144 Lot Number: 1600678

Distribution pattern

US Nationwide distribution.

device · product 11 of 73

Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06

Z-0393-2025
Recall number
Z-0393-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
144 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160423981 Lot Number: 1610366, 1610367, 1610368, 1610369

Distribution pattern

US Nationwide distribution.

device · product 12 of 73

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05

Z-0394-2025
Recall number
Z-0394-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
132 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160412930 Lot Number: 1604669

Distribution pattern

US Nationwide distribution.

device · product 13 of 73

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06

Z-0395-2025
Recall number
Z-0395-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
129 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160426210 Lot Number: 1611448

Distribution pattern

US Nationwide distribution.

device · product 14 of 73

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02

Z-0396-2025
Recall number
Z-0396-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
165 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160366479 Lot Number: 1600550

Distribution pattern

US Nationwide distribution.

device · product 15 of 73

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03

Z-0397-2025
Recall number
Z-0397-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
174 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160426463 Lot Number: 1597676

Distribution pattern

US Nationwide distribution.

device · product 16 of 73

Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

Z-0398-2025
Recall number
Z-0398-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
72 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160394595 Lot Number: 1589794

Distribution pattern

US Nationwide distribution.

device · product 17 of 73

Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

Z-0399-2025
Recall number
Z-0399-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160366707 Lot Number: 1590888

Distribution pattern

US Nationwide distribution.

device · product 18 of 73

Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06

Z-0400-2025
Recall number
Z-0400-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
24 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160365755 Lot Number: 1587717

Distribution pattern

US Nationwide distribution.

device · product 19 of 73

Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09

Z-0401-2025
Recall number
Z-0401-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
60 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160365779 Lot Number: 1596070

Distribution pattern

US Nationwide distribution.

device · product 20 of 73

Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

Z-0402-2025
Recall number
Z-0402-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
14 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160398951 Lot Number: 1597182

Distribution pattern

US Nationwide distribution.

device · product 21 of 73

Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06

Z-0403-2025
Recall number
Z-0403-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
137 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160393512 Lot Number: 1592938, 1594966

Distribution pattern

US Nationwide distribution.

device · product 22 of 73

Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25

Z-0404-2025
Recall number
Z-0404-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
42 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160368169 Lot Number: 1603717

Distribution pattern

US Nationwide distribution.

device · product 23 of 73

Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19

Z-0405-2025
Recall number
Z-0405-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
136 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160368237 Lot Number: 1597709

Distribution pattern

US Nationwide distribution.

device · product 24 of 73

Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34

Z-0406-2025
Recall number
Z-0406-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
308 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160380888 Lot Number: 1590497, 1601534

Distribution pattern

US Nationwide distribution.

device · product 25 of 73

Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29

Z-0407-2025
Recall number
Z-0407-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
36 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160368329 Lot Number: 1594075

Distribution pattern

US Nationwide distribution.

device · product 26 of 73

Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19

Z-0408-2025
Recall number
Z-0408-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
12 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160368367 Lot Number: 1588253

Distribution pattern

US Nationwide distribution.

device · product 27 of 73

Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29

Z-0409-2025
Recall number
Z-0409-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
12 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160368527 Lot Number: 1596722

Distribution pattern

US Nationwide distribution.

device · product 28 of 73

Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16

Z-0410-2025
Recall number
Z-0410-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
22 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160360767 Lot Number: 1608931

Distribution pattern

US Nationwide distribution.

device · product 29 of 73

Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18

Z-0411-2025
Recall number
Z-0411-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
30 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160345658 Lot Number: 1594486, 1594624

Distribution pattern

US Nationwide distribution.

device · product 30 of 73

Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18

Z-0412-2025
Recall number
Z-0412-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160316436 Lot Number: 1591425, 1597157

Distribution pattern

US Nationwide distribution.

device · product 31 of 73

Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

Z-0413-2025
Recall number
Z-0413-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
12 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160316481 Lot Number: 1572713

Distribution pattern

US Nationwide distribution.

device · product 32 of 73

Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01

Z-0414-2025
Recall number
Z-0414-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
176 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160421772 Lot Number: 1605588, 1605589

Distribution pattern

US Nationwide distribution.

device · product 33 of 73

Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04

Z-0415-2025
Recall number
Z-0415-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
44 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160404201 Lot Number: 1597105,1605626

Distribution pattern

US Nationwide distribution.

device · product 34 of 73

Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03

Z-0416-2025
Recall number
Z-0416-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
62 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160404188 Lot Number: 1589527

Distribution pattern

US Nationwide distribution.

device · product 35 of 73

Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03

Z-0417-2025
Recall number
Z-0417-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160411995 Lot Number: 1598132

Distribution pattern

US Nationwide distribution.

device · product 36 of 73

Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03

Z-0418-2025
Recall number
Z-0418-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
411 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160410172 Lot Number: 1587478

Distribution pattern

US Nationwide distribution.

device · product 37 of 73

Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03

Z-0419-2025
Recall number
Z-0419-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
96 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160321676 Lot Number: 1608129, 1608518, 1610934

Distribution pattern

US Nationwide distribution.

device · product 38 of 73

Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02

Z-0420-2025
Recall number
Z-0420-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
96 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160321683 Lot Number: 1610935, 1614208

Distribution pattern

US Nationwide distribution.

device · product 39 of 73

Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005

Z-0421-2025
Recall number
Z-0421-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
96 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160321706 Lot Number: 1607501, 1608148, 1608519

Distribution pattern

US Nationwide distribution.

device · product 40 of 73

Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03

Z-0422-2025
Recall number
Z-0422-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
300 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160348895 Lot Number: 1608213, 1610445, 1611447, 1615322, 1619673

Distribution pattern

US Nationwide distribution.

device · product 41 of 73

Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13

Z-0423-2025
Recall number
Z-0423-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
12 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160410141 Lot Number: 1589639

Distribution pattern

US Nationwide distribution.

device · product 42 of 73

Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11

Z-0424-2025
Recall number
Z-0424-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
14 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160381991 Lot Number: 1583045

Distribution pattern

US Nationwide distribution.

device · product 43 of 73

Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13

Z-0425-2025
Recall number
Z-0425-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
14 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160382172 Lot Number: 1595070

Distribution pattern

US Nationwide distribution.

device · product 44 of 73

Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15

Z-0426-2025
Recall number
Z-0426-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
29 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160382172 Lot Number: 1595714

Distribution pattern

US Nationwide distribution.

device · product 45 of 73

Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15

Z-0427-2025
Recall number
Z-0427-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
24 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160384206 Lot Number: 1590860, 1593416

Distribution pattern

US Nationwide distribution.

device · product 46 of 73

Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

Z-0428-2025
Recall number
Z-0428-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
14 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160395189 Lot Number: 1591258

Distribution pattern

US Nationwide distribution.

device · product 47 of 73

Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

Z-0429-2025
Recall number
Z-0429-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
33 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160370186 Lot Number: 1586050, 1586407, 1605747

Distribution pattern

US Nationwide distribution.

device · product 48 of 73

Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15

Z-0430-2025
Recall number
Z-0430-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
216 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160388495 Lot Number: 1589652, 1595715

Distribution pattern

US Nationwide distribution.

device · product 49 of 73

Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02

Z-0431-2025
Recall number
Z-0431-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
288 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160371800 Lot Number: 1600943, 1600944, 1600945

Distribution pattern

US Nationwide distribution.

device · product 50 of 73

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06

Z-0432-2025
Recall number
Z-0432-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
81 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160417126 Lot Number: 1599174

Distribution pattern

US Nationwide distribution.

device · product 51 of 73

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07

Z-0433-2025
Recall number
Z-0433-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
42 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160427224 Lot Number: 1612993

Distribution pattern

US Nationwide distribution.

device · product 52 of 73

Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04

Z-0434-2025
Recall number
Z-0434-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
60 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160413470 Lot Number: 1608261

Distribution pattern

US Nationwide distribution.

device · product 53 of 73

Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02

Z-0435-2025
Recall number
Z-0435-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
20 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160420072 Lot Number: 1610500

Distribution pattern

US Nationwide distribution.

device · product 54 of 73

Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02

Z-0436-2025
Recall number
Z-0436-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
36 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160420089 Lot Number: 1604218

Distribution pattern

US Nationwide distribution.

device · product 55 of 73

Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

Z-0437-2025
Recall number
Z-0437-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
42 eahes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160332719 Lot Number: 1603736

Distribution pattern

US Nationwide distribution.

device · product 56 of 73

Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04

Z-0438-2025
Recall number
Z-0438-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
44 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160332733 Lot Number: 1603839

Distribution pattern

US Nationwide distribution.

device · product 57 of 73

Halyard EP PACK - Medical convenience kits Model Number: VANW018-06

Z-0439-2025
Recall number
Z-0439-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
12 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160401941 Lot Number: 1598601

Distribution pattern

US Nationwide distribution.

device · product 58 of 73

Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04

Z-0440-2025
Recall number
Z-0440-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
88 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160379462 Lot Number: 1609032

Distribution pattern

US Nationwide distribution.

device · product 59 of 73

Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05

Z-0441-2025
Recall number
Z-0441-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
138 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160381243 Lot Number: 1594310, 1600532

Distribution pattern

US Nationwide distribution.

device · product 60 of 73

Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01

Z-0442-2025
Recall number
Z-0442-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
40 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160360798 Lot Number: 1590849

Distribution pattern

US Nationwide distribution.

device · product 61 of 73

Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06

Z-0443-2025
Recall number
Z-0443-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
33 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160333327 Lot Number: 1588570, 1596857

Distribution pattern

US Nationwide distribution.

device · product 62 of 73

Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08

Z-0444-2025
Recall number
Z-0444-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
64 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160416303 Lot Number: 1608916, 1608917

Distribution pattern

US Nationwide distribution.

device · product 63 of 73

Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08

Z-0445-2025
Recall number
Z-0445-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
45 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160416310 Lot Number: 1597663

Distribution pattern

US Nationwide distribution.

device · product 64 of 73

Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04

Z-0446-2025
Recall number
Z-0446-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
0 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160367995 Lot Number: 1595421

Distribution pattern

US Nationwide distribution.

device · product 65 of 73

Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06

Z-0447-2025
Recall number
Z-0447-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
114 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160334287 Lot Number: 1572642

Distribution pattern

US Nationwide distribution.

device · product 66 of 73

Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03

Z-0448-2025
Recall number
Z-0448-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
232 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160334904 Lot Number: 1599372, 1607988

Distribution pattern

US Nationwide distribution.

device · product 67 of 73

Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

Z-0449-2025
Recall number
Z-0449-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
24 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160334935 Lot Number: 1583502, 1605477

Distribution pattern

US Nationwide distribution.

device · product 68 of 73

Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03

Z-0450-2025
Recall number
Z-0450-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
24 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160393918 Lot Number: 1603129, 1605478

Distribution pattern

US Nationwide distribution.

device · product 69 of 73

Halyard ENT - Medical convenience kits Model Number: VMED011-01

Z-0451-2025
Recall number
Z-0451-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
21 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160334980 Lot Number: 1582596

Distribution pattern

US Nationwide distribution.

device · product 70 of 73

Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02

Z-0452-2025
Recall number
Z-0452-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
174 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160335086 Lot Number: 1581222, 1588583, 1592111

Distribution pattern

US Nationwide distribution.

device · product 71 of 73

Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10

Z-0453-2025
Recall number
Z-0453-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
6 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160335536 Lot Number: 1599244

Distribution pattern

US Nationwide distribution.

device · product 72 of 73

Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

Z-0454-2025
Recall number
Z-0454-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
56 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160363638 Lot Number: 1601647

Distribution pattern

US Nationwide distribution.

device · product 73 of 73

Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05

Z-0455-2025
Recall number
Z-0455-2025
Initiated
September 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
284 eaches

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Code information

GTIN: 10809160374122 Lot Number: 1585441, 1602960, 1606379

Distribution pattern

US Nationwide distribution.