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
Aequita Pharmacy
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vi...
Drugs·160 affected·Jul 18, 2025
High RiskFDA
Aequita Pharmacy
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dos...
Drugs·158 affected·Jul 18, 2025
High RiskFDA
Aequita Pharmacy
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vi...
Drugs·139 affected·Jul 18, 2025
High RiskFDA
Aequita Pharmacy
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vi...
Drugs·143 affected·Jul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Produc...
Surgical Devices·907 affected·Jul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Des...
Medical Implants·439 affected·Jul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description...
Surgical Devices·927 affected·Jul 18, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Descripti...
Surgical Devices·447 affected·Jul 18, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNE...
Medical Devices·588 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR ...
Medical Devices·781 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2...
Medical Devices·204 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCU...
Cardiac Devices·31,506 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; ...
Cardiac Devices·6,617 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE P...
Medical Devices·1,233 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCO...
Medical Devices·1,094 affected·Jul 14, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Im...
Ophthalmic Drugs·2,890 affected·Jul 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The ki...
Medical Devices·1,145 affected·Jul 8, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs·154,176 affected·Jul 5, 2025
High RiskFDA
Central Admixture Pharmacy Services, Inc (caps) Los Angeles
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, ...
Injectable Drugs·2 affected·Jul 1, 2025
High RiskFDA
Cipla Usa, Inc.
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indo...
Drugs·13,680 affected·Jun 30, 2025
CriticalFDA
Sandoz Inc
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sa...
Injectable Drugs·208,300 affected·Jun 27, 2025
CriticalFDA
Sandoz Inc
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Aus...
Injectable Drugs·0 affected·Jun 27, 2025
High RiskFDA
Spiggle & Theis Mt Gmbh
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-...
Medical Devices·0 affected·Jun 27, 2025
High RiskFDA
Orthofix U.s. Llc
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Medical Devices·3 affected·Jun 24, 2025
High RiskFDA
Olympus Corporation Of The Americas
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resec...
Medical Devices·11 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with G...
Medical Devices·1 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatibl...
Medical Devices·2 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El...
Medical Devices·16 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El...
Medical Devices·48 affected·Jun 18, 2025
High RiskFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medica...
Injectable Drugs·187,656 affected·Jun 16, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOO...
Medical Devices·15,700 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
Medical Devices·184 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Medical Devices·48 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Medical Devices·960 affected·Jun 12, 2025
High RiskFDA
Bridge To Life Ltd
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number R...
Medical Devices·4,528 affected·Jun 12, 2025
High RiskFDA
Coopersurgical, Inc.
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Medical Devices·475 affected·Jun 11, 2025
High RiskFDA
Boston Scientific Corporation
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Use...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/4...
Medical Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and co...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 4...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression Sys...
Medical Implants·70,516 affected·Jun 6, 2025
High RiskFDA
Waismed Ltd.
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Descriptio...
Medical Devices·516 affected·Jun 5, 2025
High RiskFDA
Waismed Ltd.
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Descripti...
Medical Devices·7,056 affected·Jun 5, 2025
High RiskFDA
Tailstorm Health Inc
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Offic...
Injectable Drugs·23,200 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Cauda...
Injectable Drugs·2,825 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use ...
Injectable Drugs·14,725 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For ...
Injectable Drugs·975 affected·Jun 2, 2025
High RiskFDA
Tailstorm Health Inc
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Includi...
Injectable Drugs·29,700 affected·Jun 2, 2025