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
Abbott Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Medical Implants·302 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Medical Implants·21,843 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Medical Implants·38 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Medical Implants·1,119 affected·May 16, 2024
High RiskFDA
Abbott Medical
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Medical Implants·30,673 affected·May 16, 2024
High RiskFDA
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx...
Injectable Drugs·405,725 affected·May 15, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimi...
Ophthalmic Drugs·4,280 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injectio...
Injectable Drugs·38,060 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 W...
Injectable Drugs·165,920 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
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...
Injectable Drugs·18,980 affected·May 14, 2024
High RiskFDA
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd f...
Injectable Drugs·4,136 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1...
Injectable Drugs·74,440 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF...
Injectable Drugs·39,700 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OF...
Ophthalmic Drugs·136,005 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. ...
Injectable Drugs·14,180 affected·May 14, 2024
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardio...
Medical Devices·45,828 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material ...
Medical Devices·306,000 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic sur...
Medical Devices·341,532 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue,...
Medical Devices·56,952 affected·May 10, 2024
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, ...
Surgical Devices·6 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for o...
Medical Devices·55,296 affected·May 10, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Pacira Pharmaceuticals Inc
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: P...
Injectable Drugs·43,768 affected·May 7, 2024
High RiskFDA
Smith & Nephew Inc
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Medical Devices·23 affected·Apr 24, 2024
High RiskFDA
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron ...
Injectable Drugs·251,504 affected·Apr 23, 2024
CriticalFDA
Revive Rx Llc Dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf ...
Drugs·751 affected·Apr 20, 2024
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 600...
Ophthalmic Drugs·15,444 affected·Apr 19, 2024
High RiskFDA
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis,...
Ophthalmic Drugs·6,960 affected·Apr 19, 2024
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, I...
Ophthalmic Drugs·4,648 affected·Apr 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Medical Devices·1,822 affected·Apr 17, 2024
High RiskFDA
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Surgical Devices·5,604 affected·Apr 17, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC...
Ophthalmic Drugs·3,320 affected·Apr 10, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pac...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRC...
Surgical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack N...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTER...
Surgical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without ne...
Medical Devices·60,000 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without nee...
Medical Devices·325,500 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needl...
Medical Devices·525,700 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without ne...
Medical Devices·18,900 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without n...
Medical Devices·7,750 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Desc...
Medical Devices·724,500 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles f...
Medical Devices·139,100 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without...
Medical Devices·12,160 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without ne...
Medical Devices·178,400 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without nee...
Medical Devices·133,600 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes witho...
Medical Devices·40,800 affected·Apr 5, 2024