Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1001–1025 of 2228

HighFDA (Devices)·Z-2724-2017·2017-07-19
ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2716-2017·2017-07-19
ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.
Product
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular sys
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2639-2017·2017-07-05
DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect
DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.
Product
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2612-2017·2017-06-28
Z-Medica Recalls QuikClot TraumaPad Due to Packaging Sterility Concerns
Z-Medica is recalling 2,910 units of QuikClot TraumaPad hemostatic dressings because packaging breaches may compromise sterility.
Product
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2334-2017·2017-06-21
Arrow International Recalls Hemodialysis Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling specific hemodialysis catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2017·2017-06-21
Arrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling single-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2017·2017-06-21
Arrow Recalls PICC Kits Due to Potential Packaging Seal Defects
Arrow International is recalling Pressure Injectable PICC Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, bl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2017·2017-06-21
Arrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise
Arrow International is recalling Arterial Catheterization Kits because packaging defects may compromise sterility.
Product
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2582-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rod Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary rod implants and accessories because packaging design verification tests failed. The recall affects 9,867 units distributed worldwide.
Product
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2565-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2330-2017·2017-06-21
Arrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue Fl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2571-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile knee implants because packaging design verification tests failed. The devices were distributed worldwide.
Product
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2329-2017·2017-06-21
Arrow International Recalls Introducer Kits Due to Potential Sterility Compromise
Arrow International is recalling Introducer Kits and Arrow PSI Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2552-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile femoral intramedullary nails and accessories because packaging design verification tests failed.
Product
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2335-2017·2017-06-21
Arrow International Recalls Two-Lumen Central Venous Access Kits
Arrow International is recalling Two-Lumen Central Venous Access Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2563-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2570-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Test Failures
Zimmer Biomet is recalling sterile knee implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2578-2017·2017-06-21
Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile porous femoral stems because packaging design verification tests failed. The recall covers units distributed worldwide.
Product
Por fullct fem st 16x200mm, Sterile,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2572-2017·2017-06-21
Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile knee implants because packaging design verification tests failed. The recall covers units distributed worldwide.
Product
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2561-2017·2017-06-21
Zimmer Biomet Recalls Sterile Tibial Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2581-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories because packaging design verification tests failed. The action covers 9,867 units distributed worldwide.
Product
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2333-2017·2017-06-21
Arrow International Recalls Central Venous Access Kits Due to Packaging Seal Issues
Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.
Product
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2600-2017·2017-06-21
Zimmer Biomet Recalls Sterile Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
Product
4.5 BROAD SCP PLT 26-H STER
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2550-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The recall covers 9,867 units distributed worldwide.
Product
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2577-2017·2017-06-21
Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile hip implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Product
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide