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.

901–925 of 2518

SevereFDA (Devices)·Z-0981-2018·2018-03-21
Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses
Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.
Product
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0991-2018·2018-03-21
Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues
Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2018·2018-03-21
Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1072-2018·2018-03-21
Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns
Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.
Product
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1007-2018·2018-03-21
Medtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters
Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.
Product
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0918-2018·2018-03-14
Zimmer Biomet Flexible Shaft Instruments Recalled for Infection Risk
Zimmer Biomet is recalling 457 Flexible Shaft instruments because they may not clean adequately, posing a risk of infection.
Product
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0919-2018·2018-03-14
Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns
Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to infection.
Product
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0742-2018·2018-03-07
AngioDynamics Recalls Soft-Vu Omni Flush Angiographic Catheters
AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.
Product
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Category
Medical Device
Distribution
14 states
SevereFDA (Drugs)·D-0438-2018·2018-02-28
Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns
Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.
Product
Lidocaine HCl in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0433-2018·2018-02-28
Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl Injection due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Product
HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0458-2018·2018-02-28
Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.
Product
Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0454-2018·2018-02-28
Pharmedium Recalls Glycopyrrolate Due to Lack of Sterility Assurance
Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
Product
Glycopyrrolate in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0448-2018·2018-02-28
Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Methadone HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Product
Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0432-2018·2018-02-28
Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling Ephedrine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2018·2018-02-28
Pentax Video Duodenoscope Recalled to Mitigate Infection Risk
Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.
Product
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2018·2018-02-21
Hemotherm Dual Reservoir Cooler/Heater System Recall for Updated Cleaning Instructions
Cincinnati Sub-Zero is recalling 1,355 Hemotherm units to provide updated instructions for cleaning and disinfection to address NTM infection risks.
Product
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2018·2018-02-21
Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization
Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.
Product
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0159-2018·2018-01-17
Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0158-2018·2018-01-17
Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 22,080 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0157-2018·2018-01-17
Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 29,232 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0160-2018·2018-01-17
Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0134-2018·2018-01-03
Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns
Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.
Product
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0213-2018·2018-01-03
Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
Product
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheath
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0295-2018·2018-01-03
Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure
Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.
Product
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0117-2018·2017-11-29
Halyard Closed Suction System Recalled for Potential Saline Vial Leaking
Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.
Product
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
Category
Medical Device
Distribution
38 states