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.

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.

2501–2525 of 3429

SevereFDA (Drugs)·D-0618-2016·2016-02-03
Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Product
INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0623-2016·2016-02-03
Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.
Product
VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Ho
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0620-2016·2016-02-03
Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.
Product
Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0585-2016·2016-01-27
Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure
Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.
Product
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0685-2016·2016-01-27
Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise
Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.
Product
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2016·2016-01-27
Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise
Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.
Product
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0684-2016·2016-01-27
Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise
Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.
Product
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0556-2016·2016-01-06
Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection in Texas due to a lack of assurance of sterility.
Product
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0544-2016·2016-01-06
Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns
Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes in Texas due to a lack of assurance of sterility.
Product
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0527-2016·2016-01-06
Walgreens Recalls Heparin Injection Syringes Due to Sterility Concerns
Walgreens Infusion Services is recalling 49 syringes of Heparin injection, Preservative Free, due to a lack of assurance of sterility. The affected products were distributed in Texas.
Product
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0470-2016·2015-12-30
Hardy Diagnostics Recalls FB Broth Due to Potential Contamination
Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.
Product
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0475-2016·2015-12-30
Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure
Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.
Product
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0416-2016·2015-12-23
Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error
Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.
Product
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0382-2016·2015-12-16
LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.
Product
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0467-2016·2015-12-09
Western Drug Recalls Vitamin B12 Injections Due to Sterility Concerns
Western Drug is recalling Vitamin B12 injections because the company cannot ensure the product is sterile. The recall covers eight containers distributed nationwide.
Product
Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0430-2016·2015-12-09
Western Drug Recalls Heparin Sodium Injection Due to Sterility Concerns
Western Drug is recalling Heparin Sodium 30,000U/30ML Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
Product
Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0446-2016·2015-12-09
Western Drug Recalls Pyridoxine B6 Injections Due to Sterility Concerns
Western Drug is recalling Pyridoxine B6 100mg injections because the company cannot ensure the product is sterile. The recall covers three containers distributed nationwide.
Product
Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0395-2016·2015-12-09
Western Drug Recalls Ace-Promazine Injection Due to Sterility Concerns
Western Drug is recalling Ace-Promazine 10 mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
Product
Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0410-2016·2015-12-09
Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Concerns
Western Drug is recalling Hydroxocobalamin 5000IU/mL Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.
Product
Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0418-2016·2015-12-09
Western Drug Recalls Ascorbic Acid Injection Due to Sterility Concerns
Western Drug is recalling Ascorbic Acid 500 mg/mL Injection because the product lacks assurance of sterility. The recall covers six containers distributed nationwide.
Product
Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0417-2016·2015-12-09
Western Drug Recalls Alcohol and Bupivicaine Solution Due to Sterility Concerns
Western Drug is recalling Alcohol 4%/Bupivicaine 0.5% solution because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.
Product
Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0456-2016·2015-12-09
Western Drug Recalls Tacrolimus Eye Drops Due to Sterility Concerns
Western Drug is recalling two containers of Tacrolimus 0.02% Opth Sol due to a lack of assurance of sterility. The product was distributed nationwide in eight states.
Product
Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0453-2016·2015-12-09
Western Drug Recalls Squaric Acid 4% Injection Due to Sterility Concerns
Western Drug is recalling Squaric Acid 4% Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
Product
Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0419-2016·2015-12-09
Western Drug Recalls Cantharitus Multi-Mix Prep Due to Sterility Concerns
Western Drug is recalling Cantharitus Multi-Mix Prep because the product lacks assurance of sterility. The recall affects all lots distributed nationwide.
Product
Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0387-2016·2015-12-02
Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns
Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.
Product
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, O
Category
Drug
Distribution
Distributed nationwide