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.

1951–1975 of 2228

ModerateFDA (Devices)·Z-0027-2015·2014-10-15
Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
Navilyst Medical is recalling BioFlo PICC kits because included BD syringes had open seals, potentially affecting sterility.
Product
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0033-2015·2014-10-15
Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise
Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.
Product
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intraven
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0026-2015·2014-10-15
Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.
Product
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, includin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0035-2015·2014-10-15
Navilyst Medical Recalls PICC Kits Due to Potential Sterility Issues
Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may compromise sterility.
Product
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, incl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2015·2014-10-15
Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise
Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.
Product
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2694-2014·2014-10-01
Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues
Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.
Product
eye-pak 7407 Tray Support Cover REF 8065740745
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2595-2014·2014-09-17
Catheter Connections Recalls DualCap IV Pole Strips Due to Packaging Seal Defect
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.
Product
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours und
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2551-2014·2014-09-03
Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures
Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.
Product
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2558-2014·2014-09-03
Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.
Product
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate o
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2546-2014·2014-09-03
Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.
Product
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2548-2014·2014-09-03
Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.
Product
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM D
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2549-2014·2014-09-03
Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures
Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.
Product
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CAN
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2547-2014·2014-09-03
Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.
Product
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2295-2014·2014-08-27
ICU Medical Recalls Port Access Kits with Potential Sterility Issues
ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.
Product
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2014·2014-08-27
ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals
ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2246-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
Product
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2293-2014·2014-08-27
ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues
ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.
Product
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2247-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Trauma Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.
Product
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2250-2014·2014-08-27
Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.
Product
4.5 mm Malleolar Screw Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2248-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.
Product
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2244-2014·2014-08-27
Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.
Product
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1442-2014·2014-07-23
CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2014·2014-07-16
Zimmer M/L Taper Hip Stem Recall Due to Black Residue
Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.
Product
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2035-2014·2014-07-16
Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue
Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.
Product
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary fo
Category
Medical Device
Distribution
Distributed nationwide