Hazard

Sterility Failure recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure 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.

76–100 of 462

HighFDA (Devices)·Z-0791-2025·2025-01-08
Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination
Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.
Product
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0051-2025·2024-11-27
Bevacizumab injection syringes recalled for lack of sterility assurance
27,560 bevacizumab injection syringes distributed nationwide are being recalled due to failure to maintain sterility assurance. The affected syringes may not be sterile.
Product
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2025·2024-11-20
Clean Catch Kit specimen containers recalled for sterility labeling failure
Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.
Product
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2253-2024·2024-07-17
BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
Product
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0515-2024·2024-06-05
Moxifloxacin intraocular injection vials recalled for sterility assurance failure
Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.
Product
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0513-2024·2024-06-05
Intraocular Injection Recalled for Sterility Assurance Failure
Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.
Product
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0531-2024·2024-06-05
EYLEA injectable eye medication recalled due to sterility and syringe breakage
Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.
Product
EYLEA — EYLEA (AFLIBERCEPT)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0509-2024·2024-06-05
Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
Product
CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2024·2024-05-29
GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
Product
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1806-2024·2024-05-22
MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility
Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.
Product
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2024·2024-04-17
ConvaTec CarboFlex Wound Dressing Recalled for Failed Sterility Standards
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
Product
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0431-2024·2024-04-10
Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage
B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.
Product
LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0435-2024·2024-04-10
Phenylephrine HCl Syringes Recalled for Sterility Assurance Failure
SSM Health Care is recalling 11,798 compounded Phenylephrine HCl intravenous syringes distributed to Missouri hospitals and medical offices due to lack of process validation for sterility assurance.
Product
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0422-2024·2024-04-03
FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0421-2024·2024-04-03
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl 800 mcg/10 mL injections due to lack of assurance that the product is sterile. The recall affects 2,427 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID f
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0394-2024·2024-04-03
Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
Product
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0416-2024·2024-04-03
PHENYLephrine Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0400-2024·2024-04-03
Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2024·2024-04-03
Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0424-2024·2024-04-03
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.
Product
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
Product
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0370-2024·2024-03-20
Potassium Chloride Injection Recalled Due to Pinhole Container Defects
B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2024·2024-03-20
CVS Health Wound Dressing Recalled for Failed Sterility Testing
Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.
Product
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0378-2024·2024-03-20
TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance
Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Product
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0381-2024·2024-03-20
TRP Natural Eyes eye drops recalled due to lack of sterility assurance
TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.
Product
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
Category
Drug
Distribution
Distributed nationwide