The Recall Desk

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.

826–850 of 3438

  • HighFDA (Drugs)·D-0730-2022·2022-04-06

    Injectable testosterone-anastrozole mixture recalled for sterility assurance failure

    Drug Depot (APS Pharmacy) is recalling testosterone cypionate/anastrozole injectable oil due to lack of sterility assurance. The recall affects 846 vials distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0735-2022·2022-04-06

    Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

    Drug Depot recalled 17 vials of Testosterone Cypionate Injectable due to lack of sterility assurance in manufacturing. The recalled product was distributed nationwide and should not be used.

    Product
    TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0732-2022·2022-04-06

    Testosterone Cypionate Injectable Recalled Due to Lack of Sterility Assurance

    Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0728-2022·2022-04-06

    FDA Recalls Gonadorelin Injectable Vials for Lack of Sterility Assurance

    Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.

    Product
    GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0717-2022·2022-03-30

    Eye Lubricant Drops Recalled for Insufficient Sterility Assurance

    Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.

    Product
    THERATEARS EXTRA — THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2022·2022-03-30

    Biomet Fibula Composite Locking Plate Recall Due to Sterile Barrier Packaging Defect

    Biomet is recalling TRAUMA A.L.P.S. fibula composite locking plates due to packaging that may not maintain sterile barrier integrity, posing a risk of infection if used.

    Product
    BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0810-2022·2022-03-30

    BIOMET Trauma DVR CROSSLOCK implants recalled for packaging integrity

    BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.

    Product
    BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0812-2022·2022-03-30

    Biomet Trauma Surgical Instruments Recalled Due to Packaging Defect

    Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.

    Product
    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0809-2022·2022-03-30

    Biomet Surgical Implant Reamer Recall: Packaging Sterile Barrier Risk

    Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.

    Product
    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels.…
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Drugs)·D-0667-2022·2022-03-23

    Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.

    Product
    Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0658-2022·2022-03-23

    Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0662-2022·2022-03-23

    Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns

    Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.

    Product
    Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0656-2022·2022-03-23

    Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.

    Product
    Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0665-2022·2022-03-23

    Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.

    Product
    Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0780-2022·2022-03-23

    RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach

    Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.

    Product
    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2022·2022-03-23

    Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach

    Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.

    Product
    Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2022·2022-03-23

    Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.

    Product
    DREAMTOME 44-30MM/450CM Material Number: M00584070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2022·2022-03-23

    Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.

    Product
    JAGTOME RX 49-20-260-035 Material Number: M00573000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2022·2022-03-23

    Medical device sterile barrier breach compromises sterility in JAGTOME RX

    Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.

    Product
    JAGTOME RX 39-30-450-025 Material Number: M00573110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2022·2022-03-23

    Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise

    Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.

    Product
    DREAMTOME 49-30MM/260CM Material Number: M00584010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2022·2022-03-23

    Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier

    Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-450-035 Material Number: M00573050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2022·2022-03-23

    Boston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.

    Product
    HYDRATOME RX 44-20MM/260CM Material Number: M00583040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2022·2022-03-23

    Boston Scientific DREAMTOME device recalled due to sterile barrier breach

    Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.

    Product
    DREAMTOME 44-30MM/260CM Material Number: M00584050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2022·2022-03-23

    Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.

    Product
    JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
    Category
    Medical Device
    Distribution
    Distributed nationwide