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.

1251–1275 of 3429

  • 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-0984-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Testosterone Cypionate Injection 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
    Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1358-2020·2020-03-04

    Medline Robotic-LF Complete Delivery System Recall Due to Sterility Concerns

    Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.

    Product
    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1322-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new scr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2020·2020-02-26

    Nobel Biocare Guided Tapered Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2020·2020-02-26

    Cardinal Health Recalls Presource Procedure Packs with Potential Sterility Issues

    Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile due to improper environmental conditions during manufacturing.

    Product
    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2020·2020-02-26

    Nobel Biocare Recalls Tapered Drills Due to Sterility Concerns

    Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1002-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Fabric Reinforced Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1008-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1022-2020·2020-02-12

    Cardinal Health Recalls Royalsilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling approximately 7.7 million Royalsilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK LARGE, Gown. Item Code 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1003-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1004-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1016-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1020-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1040-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2020·2020-02-12

    Centurion Infant Feeding Kit Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling Infant Feeding Kits due to incomplete seals on the sterile package, which may compromise sterility.

    Product
    Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Kits Due to Incomplete Seals

    Centurion Medical Products is recalling specific sterile medical kits because incomplete seals may compromise sterility.

    Product
    Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2020·2020-02-12

    Centurion Vaginal Speculums Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.

    Product
    Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1089-2020·2020-02-12

    Centurion Nasal Speculums Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 1,820 sterile nasal speculums due to incomplete package seals that may compromise sterility.

    Product
    Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2020·2020-02-12

    Centurion Suture Tray Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling Suture Trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion-Suture Tray DYNDR1210A SUTURING TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0932-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.

    Product
    Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states