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.

2801–2825 of 3438

SevereFDA (Devices)·Z-2110-2015·2015-07-29
Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.
Product
Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2175-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2116-2015·2015-07-29
FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves
The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.
Product
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2107-2015·2015-07-29
FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves
The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2015·2015-07-29
FDA Recalls Sterile Single Basin Kits with Compromised Gloves
The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.
Product
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2015·2015-07-29
Recall of Sterile Major Kits with Defective Devon Light Gloves
FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.
Product
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2015·2015-07-29
FDA Recalls Devon Light Gloves for Sterility Compromising Defects
The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.
Product
Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2188-2015·2015-07-29
Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.
Product
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2178-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Stripper Tools Due to Sterilization Issues
American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.
Product
Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2112-2015·2015-07-29
Surgical Kits Recalled Due to Glove Splits Compromising Sterility
The FDA is recalling 114,813 surgical kits containing Devon Light Gloves due to splits or holes that compromise sterility.
Product
Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2015·2015-07-29
Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves
FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise sterility.
Product
Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2015·2015-07-29
American Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure
American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.
Product
American Catheter / Cholangiogram Catheter 9100 Series.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2166-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2015·2015-07-29
Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.
Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2160-2015·2015-07-29
FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2172-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2181-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2157-2015·2015-07-29
FDA Recalls Sureflex 200 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 200 Lithotripsy Fibers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.
Product
Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2159-2015·2015-07-29
FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2064-2015·2015-07-22
Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk
Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.
Product
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Category
Medical Device
Distribution
Distributed nationwide