Hazard

Infection recalls

2,518 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,518
Critical: 31
Severe: 1,671
Most recent: 2026-08-26

Of the 2,518 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,671 (66%) 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 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.

101–125 of 2518

HighFDA (Devices)·Z-1298-2021·2021-03-31
Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns
Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.
Product
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in stra
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0305-2021·2021-03-24
Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.
Product
PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1247-2021·2021-03-17
Medtronic Guide Catheter Recalled for Potential Sterility Compromise
Medtronic Vascular is recalling 10 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Product
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1159-2021·2021-03-10
ReNovo Recalls Reprocessed Medical Devices Shipped as Sterile
ReNovo, Inc. is recalling 81 units of reprocessed medical devices that were shipped to customers labeled as sterile but were non-sterile.
Product
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Con
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0277-2021·2021-03-03
Teva Recalls Metoclopramide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Metoclopramide Injection because manufacturing areas exceeded microbial acceptance levels, creating a lack of sterility assurance.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0285-2021·2021-03-03
Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0272-2021·2021-03-03
Teva Recalls Desmopressin Acetate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Desmopressin Acetate Injection because manufacturing areas exceeded microbial limits, compromising sterility assurance.
Product
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1138-2021·2021-03-03
DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs
DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.
Product
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1141-2021·2021-03-03
Ecolab Recalls Slush and Warmer Disc Drapes Due to Sterile Barrier Risk
Ecolab is recalling specific lots of ORS-320 Slush + Warmer Disc Drapes because manufacturing slits may breach the sterile barrier, posing an infection risk to patients.
Product
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0990-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1010-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seal
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1004-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2021·2021-02-17
Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2021·2021-02-17
Aomori Olympus Recalls K-203 Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2021·2021-02-17
Aomori Olympus Recalls B5-2Q Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages had inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found inadequate package seals. This defect may allow non-sterile equipment to be used, posing an infection risk.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2021·2021-02-17
Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide