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.

1226–1250 of 3429

  • HighFDA (Devices)·Z-1979-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 2,697 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Due to Unsealed Pouches

    Stryker is recalling 26,298 units of Spy-Phi Drapes and Packs because sterile drapes were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Packaged in Unsealed Pouches

    Stryker is recalling 21,078 units of Spy-Phi Drapes because they were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2020·2020-04-29

    Biomet Shoulder Surgery Pliers Recalled for Sterility Concerns

    Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.

    Product
    Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1090-2020·2020-04-15

    PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to a lack of sterility assurance.

    Product
    fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1087-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2020·2020-04-15

    Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise

    Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.

    Product
    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1641-2020·2020-04-15

    Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1660-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1638-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1654-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1530-2020·2020-04-01

    Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1457-2020·2020-03-18

    EHOB Recalls Econocare Plus Waffle Overlay Due to Blood Contamination

    EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlays due to potential contamination with human blood. No instances of contamination have been confirmed in distributed products.

    Product
    Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1415-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0953-2020·2020-03-11

    Axia Pharmaceutical Recalls Glutathione Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Glutathione Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2020·2020-03-11

    Axia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Human Chorionic Gonadotropin (hCG) Injection due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0971-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0973-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-B12 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-B12 Injection because the product lacks assurance of sterility. The recall covers multiple lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the company cannot assure the sterility of the product.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0951-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0986-2020·2020-03-11

    Recall of Triamcinolone Acetonide/Bupivacaine Injectable Suspension Due to Sterility Concerns

    FDA recalls Triamcinolone Acetonide/Bupivacaine Injectable Suspension due to lack of sterility assurance. The drug was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
    Category
    Drug
    Distribution
    Distributed nationwide