Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·141 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices·561 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser At...
Surgical Devices·173 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·1,019 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Lase...
Surgical Devices·795 affected·Aug 29, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesc...
Injectable Drugs·270,125 affected·Aug 27, 2025
High RiskFDA
B Braun Medical Inc
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA,...
Drugs·16,228 affected·Aug 26, 2025
High RiskFDA
B Braun Medical Inc
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Injectable Drugs·26,316 affected·Aug 26, 2025
High RiskFDA
Coopervision, Inc.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, ...
Medical Devices·4,140 affected·Aug 22, 2025
High RiskFDA
Coopervision, Inc.
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moul...
Medical Devices·90 affected·Aug 22, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·3,790 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Medical Devices·2,700 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·490 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Medical Devices·160 affected·Aug 21, 2025
RecallFDA
Medline Industries, Lp
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medlin...
Topical Drugs·2,680 affected·Aug 19, 2025
High RiskFDA
Corneat Vision, Ltd.
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Medical Devices·180 affected·Aug 18, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Medical Devices·88 affected·Aug 8, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Medical Devices·22 affected·Aug 8, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active L...
Medical Devices·15,441 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·25,778 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural ...
Medical Devices·111,492 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·330 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Descriptio...
Medical Devices·994 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·6 affected·Aug 5, 2025
High RiskFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medic...
Injectable Drugs·23,100 affected·Aug 4, 2025
High RiskFDA
B Braun Medical Inc
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical ...
Injectable Drugs·74,088 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409...
Injectable Drugs·49,620 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-...
Injectable Drugs·15,750 affected·Aug 4, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Medical Devices·57 affected·Aug 4, 2025
High RiskFDA
Lumicell, Inc.
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Mod...
Medical Devices·200 affected·Jul 31, 2025
High RiskFDA
Genogenix Llc
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·32 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·221 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·430 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·161 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·85 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, ...
Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·30 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·45 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·296 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·184 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·235 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. A...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·294 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·53 affected·Jul 30, 2025