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.

801–825 of 3429

  • HighFDA (Devices)·Z-1069-2022·2022-05-18

    Flexible Uretero-Renoscopes Recalled for Inadequate Disinfection

    Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.

    Product
    11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1047-2022·2022-05-18

    Bronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns

    Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.

    Product
    BF-3C160: EVIS EXERA Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2022·2022-05-18

    Flexible Bronchoscope Recalled Due to Inadequate Disinfection Process

    Karl Storz is recalling flexible bronchoscopes due to potential failure of the disinfection process. The devices may not eliminate microorganisms adequately, posing an infection risk to patients.

    Product
    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2022·2022-05-18

    Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall

    Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.

    Product
    BF-MP160F: EVIS EXERA Bronchofibervideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2022·2022-05-18

    Karl Storz Video Ureteroscopes May Not Be Properly Sterilized

    Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.

    Product
    11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1061-2022·2022-05-18

    Karl Storz cystoscopes recalled due to inadequate disinfection

    Karl Storz cystoscopes manufactured since January 2018 are recalled because they may not achieve required disinfection levels. Inadequate disinfection could lead to patient infection during urological procedures.

    Product
    CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1062-2022·2022-05-18

    CMOS Video Cysto-Urethroscope Disinfection Failure Puts Patients at Infection Risk

    Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.

    Product
    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1063-2022·2022-05-18

    Karl Storz HD Cysto-Urethroscope recalled for disinfection failure

    Karl Storz is recalling HD-VIEW Flexible HD Cysto-Urethroscope models that fail to adequately disinfect during processing, creating a potential infection risk. All units manufactured since January 2018 are affected.

    Product
    11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1033-2022·2022-05-11

    Johnson & Johnson Tray Ring Covers Recalled for Sterility Barrier Breach

    Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.

    Product
    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2022·2022-04-20

    Cardinal Health Surgical Gloves Recalled for Lack of Sterilization

    Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.

    Product
    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0916-2022·2022-04-20

    ROTAWIRE guidewires recalled due to potentially compromised sterile pouch seals

    Boston Scientific is recalling ROTAWIRE Drive guidewires due to potentially open pouch seals that could compromise product sterility. Affected units were distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0915-2022·2022-04-20

    Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals

    Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0742-2022·2022-04-13

    Drug recall: Papaverine hydrochloride injection due to sterility concerns

    Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.

    Product
    PAPAVERINE HYDROCHLORIDE — PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
    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-0734-2022·2022-04-06

    Testosterone Cypionate Injectable Vials Recalled for Lack of Sterility Assurance

    Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, 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-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-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 (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 B
    Category
    Medical Device
    Distribution
    28 states
  • 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-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
  • 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-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 carton
    Category
    Medical Device
    Distribution
    28 states