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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80924

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

Open FDA event record

Event summary

Timeline bucket
August 01, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
COVIDIEN LLC

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

6 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 6

Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

Z-0013-2019
Recall number
Z-0013-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 18E223462,18E223362,18F054362,18E222662,18F034762, 18F034662,18F035562,18F072862,18F072662,18F072962, 18F123062,18F122562,18F122662

Distribution pattern

US Nationwide Distribution

device · product 2 of 6

Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0014-2019
Recall number
Z-0014-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18D181262,18D181162,18E029662,18E029762,18E029862, 18E029962,18E030062,18E030162,18E030262,18E030362, 18E070962,18E071062,18E071162,18E071262,18E071362, 18E071462,18E071562,18E071662,18E131562,18E131962, 18E132062,18E132162,18E131662,18E131762,18E131862, 18E166762,18E167462,18E166862,18E166962,18E167562, 18E167162,18E167062,18E167762,18E167662,18E167262, 18E222762,18E223162,18E223062,18E222962,18E222862, 18E223662,18E223562,18E224062,18E223962,18E223862, 18E223762,18F035862,18F034962,18F034862,18F035262, 18F035162,18F035062,18F035362,18F035962,18F035762, 18F035462,18F089262,18F036262,18F036162,18F036062, 18F073062,18F072762,18F123262,18F123162,18F158462, 18F158362,18G004562

Distribution pattern

US Nationwide Distribution

device · product 3 of 6

Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0015-2019
Recall number
Z-0015-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18E030462,18E223262,18F122962

Distribution pattern

US Nationwide Distribution

device · product 4 of 6

Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0016-2019
Recall number
Z-0016-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18E071762,18E072262,18E072362,18E132262,18E132362

Distribution pattern

US Nationwide Distribution

device · product 5 of 6

Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0017-2019
Recall number
Z-0017-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18D180662,18E070362,18E222362,18F072362

Distribution pattern

US Nationwide Distribution

device · product 6 of 6

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Z-0018-2019
Recall number
Z-0018-2019
Initiated
August 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
2,730,821 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility breach due to a compromised or pinched seal defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Code information

Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362

Distribution pattern

US Nationwide Distribution