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.

3251–3275 of 3429

SevereFDA (Drugs)·D-581-2013·2013-06-12
Pentec Health Recalls Proplete 34-39 KG Intradialytic Nutrition Bags
Pentec Health is recalling Proplete 34-39 KG intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Product
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-585-2013·2013-06-12
Pentec Health Recalls Intradialytic Parenteral Nutrition Bags Due to Sterility Concerns
Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.
Product
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1501-2013·2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2013·2013-06-12
Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1493-2013·2013-06-12
Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.
Product
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1502-2013·2013-06-12
Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Product
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1496-2013·2013-06-12
Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.
Product
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the tr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1504-2013·2013-06-12
Stryker Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
Product
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2013·2013-06-12
Stryker T4 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1505-2013·2013-06-12
American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect
American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.
Product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2013·2013-06-12
Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the tr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1503-2013·2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.
Product
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1492-2013·2013-06-12
Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach
Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1490-2013·2013-06-12
Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1494-2013·2013-06-12
Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1497-2013·2013-06-12
Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1500-2013·2013-06-12
Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.
Product
Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-481-2013·2013-06-05
Nora Apothecary Recalls Hydroxycobalamin Injections Due to Sterility Concerns
Nora Apothecary is recalling Hydroxycobalamin Injections because FDA inspections raised concerns about quality control and sterility assurance.
Product
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-492-2013·2013-06-05
Nora Apothecary Recalls M.I.C.+B12 Injections Due to Sterility Concerns
Nora Apothecary and Alternative Therapies, Inc. is recalling M.I.C.+B12 Inj MDV products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-462-2013·2013-06-05
Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns
Nora Apothecary is recalling 72 units of Trimix Penile Injection nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-321-2013·2013-05-22
Green Valley Drugs Recalls Methylprednisolone Injectable Suspension Due to Sterility Failure
Green Valley Drugs is recalling Methylprednisolone Preservative Free 40 mg/mL injectable suspension because testing revealed positive sterility results.
Product
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-378-2013·2013-05-22
FDA Recalls L-Glutathione Injection Due to Sterility Assurance Concerns
Green Valley Drugs is recalling L-Glutathione Injection vials because the FDA identified a lack of sterility assurance and quality control concerns.
Product
L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-340-2013·2013-05-22
Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.
Product
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-339-2013·2013-05-22
FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns
Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.
Product
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-343-2013·2013-05-22
Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.
Product
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide