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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97592

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

Open FDA event record

Event summary

Timeline bucket
September 26, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ASP Global, LLC. dba Anatomy Supply Partners, 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

24 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 24

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0544-2026
Recall number
Z-0544-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
78000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003

Distribution pattern

Distribution US nationwide and Canada.

device · product 2 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0545-2026
Recall number
Z-0545-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
50050

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7120 GTIN (Inner Pack): 30643351000087 UDI-DI: 10643351000144 All Lots produced from 01AUG2023 to 28FEB2025: 24H4127, 24I4326, 24J4134, 24J4344, 24K4370, 24L4005, 25B4103

Distribution pattern

Distribution US nationwide and Canada.

device · product 3 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0546-2026
Recall number
Z-0546-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
64850

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7121 GTIN (Inner Pack): 30643351000155 UDI-DI: 10643351000151 All Lots produced from 01AUG2023 to 28FEB2025: 23J4038, 24B4194, 24B4195, 24D4020, 24H4128, 24J4337

Distribution pattern

Distribution US nationwide and Canada.

device · product 4 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0547-2026
Recall number
Z-0547-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
27950

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7150 GTIN (Inner Pack): 30643351000162 UDI-DI: 10643351000168 All Lots produced from 01AUG2023 to 28FEB2025: 23I4024, 24B4196, 24H4129, 24J4135, 24J4345, 25B4104

Distribution pattern

Distribution US nationwide and Canada.

device · product 5 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0548-2026
Recall number
Z-0548-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
6600

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7151 GTIN (Inner Pack): 30643351000179 UDI-DI: 10643351000175 All Lots produced from 01AUG2023 to 28FEB2025: 24I4329, 24J4346, 25B4105

Distribution pattern

Distribution US nationwide and Canada.

device · product 6 of 24

AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0549-2026
Recall number
Z-0549-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
49000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7220 GTIN (Inner Pack): 30643351000094 UDI-DI: 10643351000090 All Lots produced from 01AUG2023 to 28FEB2025: 23H4114, 23I4054, 23J4036, 24A4107, 24H4123, 24I4324, 24L4007

Distribution pattern

Distribution US nationwide and Canada.

device · product 7 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0550-2026
Recall number
Z-0550-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
9150

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7221 GTIN (Inner Pack): 30643351000100 UDI-DI: 10643351000106 All Lots produced from 01AUG2023 to 28FEB2025: 24K4083, 24K4371, 25B4100

Distribution pattern

Distribution US nationwide and Canada.

device · product 8 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0551-2026
Recall number
Z-0551-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
103200

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7250 GTIN (Inner Pack): 30643351000117 UDI-DI: 10643351000113 All Lots produced from 01AUG2023 to 28FEB2025: 23H4115, 23I4023, 23J4037, 24B4193, 24D4019, 24H4124, 24I4325, 24J4238, 24L4006, 25B4101

Distribution pattern

Distribution US nationwide and Canada.

device · product 9 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0552-2026
Recall number
Z-0552-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
6050

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7251 GTIN (Inner Pack): 30643351000124 UDI-DI: 10643351000120 All Lots produced from 01AUG2023 to 28FEB2025: 24K4001, 25B4102

Distribution pattern

Distribution US nationwide and Canada.

device · product 10 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0553-2026
Recall number
Z-0553-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
2100

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7340 GTIN (Inner Pack): 30643351000131 UDI-DI: 10643351000137 All Lots produced from 01AUG2023 to 28FEB2025: 24B4201, 24K4372

Distribution pattern

Distribution US nationwide and Canada.

device · product 11 of 24

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

Z-0554-2026
Recall number
Z-0554-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
1500

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 7450 GTIN (Inner Pack): 30643351000193 UDI-DI: 10643351000199 All Lots produced from 01AUG2023 to 28FEB2025: 23H4158

Distribution pattern

Distribution US nationwide and Canada.

device · product 12 of 24

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Z-0555-2026
Recall number
Z-0555-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
2000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0507 GTIN (Inner Pack): 30643351000391 UDI-DI: 10643351000397 All Lots produced from 31JUL2023 to 28FEB2025: 24B4200

Distribution pattern

Distribution US nationwide and Canada.

device · product 13 of 24

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube

Z-0556-2026
Recall number
Z-0556-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
209000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0508 GTIN : 30643351000384 UDI-DI: 10643351000380 All Lots produced from 1AUG2020 to 28FEB2025: 21F4062, 21L4388, 22G4487, 23C4341, 23F4164, 23G4172, 23G4210, 24I4053, 24I4327, 24I4330, 24I4331, 24I4409, 24J4141, 24J4350

Distribution pattern

Distribution US nationwide and Canada.

device · product 14 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Z-0557-2026
Recall number
Z-0557-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
397000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0186 GTIN (Inner Pack): 30643351000278 UDI-DI: 10643351000274 ***All Lots produced from 31JUL2023 to 28FEB2025: 23H4108, 23H4155, 23I4014, 23I4062, 23J4040, 24F4188, 24I4314, 24L4002, 25B4097

Distribution pattern

Distribution US nationwide and Canada.

device · product 15 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube

Z-0558-2026
Recall number
Z-0558-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
352750

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0187 GTIN (Inner Pack): 30643351000285 UDI-DI: 10643351000281 All Lots produced from 31JUL2023 to 28FEB2025: 23I4063, 24A4108, 24B4197, 24D4023, 24E4137, 24E4278, 24L4004

Distribution pattern

Distribution US nationwide and Canada.

device · product 16 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube

Z-0559-2026
Recall number
Z-0559-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
77500

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0199 GTIN (Inner Pack): 30643351000322 UDI-DI: 10643351000328 All Lots produced from 31JUL2023 to 28FEB2025: 24B4199, 24E4128, 25B4098

Distribution pattern

Distribution US nationwide and Canada.

device · product 17 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube

Z-0560-2026
Recall number
Z-0560-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
1000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0005 GTIN (Inner Pack): 30643351000292 UDI-DI: 10643351000298 All Lots produced from 31JUL2023 to 28FEB2025: 23I4004

Distribution pattern

Distribution US nationwide and Canada.

device · product 18 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube

Z-0561-2026
Recall number
Z-0561-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
947100

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0007 GTIN (Inner Pack): 30643351000308 UDI-DI: 10643351000304 All Lots produced from 31JUL2023 to 28FEB2025: 23I4008, 24D4024, 24D4155, 24E4126, 24E4127, 24E4287

Distribution pattern

Distribution US nationwide and Canada.

device · product 19 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube

Z-0562-2026
Recall number
Z-0562-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
160250

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0009 GTIN (Inner Pack): 30643351000315 UDI-DI: 10643351000311 All Lots produced from 31JUL2023 to 28FEB2025: 23H4156, 23I4015, 24B4198, 24F4187, 24I4313, 24J4133

Distribution pattern

Distribution US nationwide and Canada.

device · product 20 of 24

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube

Z-0563-2026
Recall number
Z-0563-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
121750

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0185 GTIN (Inner Pack): 30643351000261 UDI-DI: 10643351000267 All Lots produced from 31JUL2023 to 28FEB2025: 23I4061, 24D4022, 24F4009, 24F4186

Distribution pattern

Distribution US nationwide and Canada.

device · product 21 of 24

SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube

Z-0564-2026
Recall number
Z-0564-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
620502

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189

Distribution pattern

Distribution US nationwide and Canada.

device · product 22 of 24

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

Z-0565-2026
Recall number
Z-0565-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
16920

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 9502 GTIN (Inner Pack): 30643351000353 UDI-DI: 10643351000359 All Lots produced from 01JUN2022 to 28FEB2025: 21G4272, 22F4084, 22F4109, 23A4170, 23H4154, 23H4228, 23I4057, 23I4058

Distribution pattern

Distribution US nationwide and Canada.

device · product 23 of 24

Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

Z-0566-2026
Recall number
Z-0566-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
50250

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131

Distribution pattern

Distribution US nationwide and Canada.

device · product 24 of 24

SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

Z-0567-2026
Recall number
Z-0567-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Quantity
27100

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
inadequate quality system to include unvalidated manufacturing processes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information

Model Number: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029

Distribution pattern

Distribution US nationwide and Canada.