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.

3026–3050 of 3438

SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1462-2014·2014-07-30
Trinity Care Solutions Recalls Nafcillin Due to Sterility Concerns
Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Product
Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1442-2014·2014-07-23
CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2045-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
Product
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2014·2014-07-16
Mizuho Doppler Probe Recalled Due to Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.
Product
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1998-2014·2014-07-16
Mizuho Disposable Doppler Probe Recalled for Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.
Product
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1995-2014·2014-07-16
Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect
Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.
Product
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2014·2014-07-09
Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects
Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 474 cases distributed across 15 states.
Product
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1954-2014·2014-07-09
Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects
Medical Action Industries is recalling Max Barrier Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1953-2014·2014-07-09
Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects
Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1950-2014·2014-07-09
Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects
Medical Action Industries is recalling sterile laceration trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1957-2014·2014-07-09
Medical Action Industries Recalls Laceration Kits Due to Seal Defects
Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
Product
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1956-2014·2014-07-09
McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals
Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.
Product
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
Category
Medical Device
Distribution
15 states
SevereFDA (Drugs)·D-1395-2014·2014-06-25
John W Hollis Recalls Levocarnitine Injection Due to Sterility Concerns
John W Hollis Inc. is recalling Levocarnitine Solution for injection because the company cannot ensure the product is sterile. The recall covers specific lots distributed nationwide.
Product
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1404-2014·2014-06-25
John W Hollis Inc Recalls Lipotropic Gold Injectable Due to Sterility Concerns
John W Hollis Inc is recalling 80 mL vials of Lipotropic Gold injectable products because they may lack sterility assurance.
Product
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1398-2014·2014-06-25
John W Hollis Inc Recalls B-Complex/Adenosine Injectable Solution for Sterility Concerns
John W Hollis Inc is recalling B-Complex/Adenosine Injectable Solution due to a lack of sterility assurance in the compounded aseptically filled products.
Product
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1400-2014·2014-06-25
John W Hollis Inc Recalls Compounded Injectable Drugs Due to Sterility Concerns
John W Hollis Inc is recalling compounded Papaverine HCl and Phentolamine Mesylate injectable products due to a lack of assurance of sterility.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1401-2014·2014-06-25
John W Hollis Inc Recalls Compounded Injectable Drug Due to Sterility Concerns
John W Hollis Inc is recalling a compounded injectable drug product due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2014·2014-06-11
FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
Product
Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1694-2014·2014-06-11
Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise
Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.
Product
Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1354-2014·2014-06-04
Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure
Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.
Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1624-2014·2014-05-28
Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect
Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2014·2014-05-28
Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect
Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.
Product
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
Category
Medical Device
Distribution
Distributed nationwide