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.

801–825 of 3438

  • HighFDA (Drugs)·D-0923-2022·2022-06-01

    Pyridoxine Injection Vials Recalled by FDA Due to Sterility Failure

    Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.

    Product
    Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0919-2022·2022-06-01

    Compounded Injectable Drug Recalled Due to Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.

    Product
    AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0929-2022·2022-06-01

    Compounded Injectable Medication Recalled Due to Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.

    Product
    Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0937-2022·2022-06-01

    MICC Injectable Drug Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0912-2022·2022-06-01

    FDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.

    Product
    Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0940-2022·2022-06-01

    Injectable pharmaceutical vial recalled due to sterility assurance failure

    Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.

    Product
    NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2022·2022-06-01

    Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.

    Product
    Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2022·2022-06-01

    Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity

    Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.

    Product
    Surgical Suture Kit
    Category
    Medical Device
    Distribution
    1 state
  • 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-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-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-1067-2022·2022-05-18

    Flexible Ureteroscope Recall Due to Inadequate Disinfection Process

    Karl Storz Endoscopy is recalling flexible ureteroscopes manufactured or distributed since January 2018 due to the disinfection process failing to achieve expected microbial reduction levels.

    Product
    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1…
    Category
    Medical Device
    Distribution
    52 states
  • 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…
    Category
    Medical Device
    Distribution
    52 states
  • 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-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-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…
    Category
    Medical Device
    Distribution
    52 states
  • 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-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-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 (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 (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-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