The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 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 988 (29%) are Severe.

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 3429

  • 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, incl
    Category
    Medical Device
    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-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 thr
    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 10
    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 ad
    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 Radi
    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-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 Inte
    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 indicati
    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/ Nat
    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 ser
    Category
    Medical Device
    Distribution
    18 states
  • 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
  • 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
  • SevereFDA (Drugs)·D-1462-2014·2014-07-30

    Trinity Care Solutions Recalls Nafcillin Due to Sterility Concerns

    Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • 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-2045-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach

    Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach

    Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2014·2014-07-16

    Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect

    Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.

    Product
    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2014·2014-07-16

    Mizuho Doppler Probe Recalled Due to Sterile Barrier Penetration

    Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.

    Product
    07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1998-2014·2014-07-16

    Mizuho Disposable Doppler Probe Recalled for Sterile Barrier Penetration

    Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.

    Product
    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state