Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,438
Critical: 25
Severe: 993
Most recent: 2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

3001–3025 of 3438

HighFDA (Devices)·Z-0163-2015·2014-11-12
C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets
C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.
Product
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle…
Category
Medical Device
Distribution
9 states
SevereFDA (Drugs)·D-0058-2015·2014-11-05
Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% ophthalmic solution due to quality control issues that may compromise sterility.
Product
Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0119-2015·2014-11-05
Martin Avenue Pharmacy Recalls Phenylephrine Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 1% injectable vials because quality control issues may compromise sterility assurance.
Product
Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0116-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
Product
PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0109-2015·2014-11-05
Martin Avenue Pharmacy Recalls Paraben Water for Injection Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Paraben water for injection because quality control observations during an FDA inspection raised concerns about sterility assurance.
Product
Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0142-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tobramycin Eye Drops for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.
Product
Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0146-2015·2014-11-05
Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Product
Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0139-2015·2014-11-05
Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise sterility assurance.
Product
Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0134-2015·2014-11-05
Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including sodium tetradecyl sulfate, due to quality control issues affecting sterility assurance.
Product
Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0012-2015·2014-10-15
Unique Pharmaceutical Recalls Sterile Products Due to Sterility Assurance Issues
Unique Pharmaceutical, Ltd is recalling all sterile products due to poor aseptic production practices identified by an FDA inspection.
Product
All sterile products within expiry
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0052-2015·2014-10-15
Zoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling 237 cases of Zoll Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The affected lots were distributed worldwide.
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0032-2015·2014-10-15
Navilyst Medical Recalls PICC Kits with Compromised Sterility
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 Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0055-2015·2014-10-15
Bio-Detek Recalls ZOLL Pro-padz Sterile Adult Electrodes Due to Sterility Concerns
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 41 single units distributed worldwide.
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0053-2015·2014-10-15
ZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The recall affects lots 1614 and 1814 distributed worldwide.
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0028-2015·2014-10-15
Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects
Navilyst Medical is recalling BioFlo PICC Kits because they contain BD syringes with open seals that may compromise sterility.
Product
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, 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
HighFDA (Devices)·Z-0054-2015·2014-10-15
ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns
Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases distributed worldwide.
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma…
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
HighFDA (Devices)·Z-2658-2014·2014-09-24
ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns
Bio-Detek is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2014·2014-09-24
Volcano TrakBack II Disposable Pullback Device Recalled for Sterility Concerns
Volcano Corporation is recalling TrakBack II Disposable Pullback Devices because internal testing identified a potential breach to the sterile barrier that may impact product sterility.
Product
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2660-2014·2014-09-24
ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2659-2014·2014-09-24
ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues
Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2288-2014·2014-08-27
Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk
Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.
Product
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
Category
Medical Device
Distribution
18 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-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