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
American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit
Medical Devices·36 affected·Aug 7, 2024
High RiskFDA
Zeco Llc
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold...
Drugs·604 affected·Aug 5, 2024
High RiskFDA
Zeco Llc
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), ...
Drugs·0 affected·Aug 5, 2024
High RiskFDA
Empower Clinic Services Llc
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: ...
Injectable Drugs·2,797 affected·Aug 2, 2024
High RiskFDA
Cardinal Health 200, Llc
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Ste...
Medical Devices·24,761,100 affected·Jul 24, 2024
High RiskFDA
Cypress Medical Products Llc
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Medical Devices·24,693,200 affected·Jul 24, 2024
High RiskFDA
Tmj Solutions Inc
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, RE...
Medical Implants·1 affected·Jul 24, 2024
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·362,544 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Medical Devices·27,971 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARY...
Medical Devices·251,591 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Medical Devices·9,133 affected·Jul 18, 2024
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Medical Devices·141,196 affected·Jul 18, 2024
CriticalFDA
Covidien
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Medical Devices·75,544 affected·Jul 9, 2024
High RiskFDA
Covidien
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Medical Devices·68,093 affected·Jul 9, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by...
Injectable Drugs·2,088 affected·Jul 2, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Medical Devices·120,960 affected·Jun 26, 2024
High RiskFDA
Smiths Medical Asd Inc.
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Medical Devices·2,881,080 affected·Jun 26, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx...
Drugs·183 affected·Jun 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
CRANIOTOMY PACK, Pack Number DYNJ46552O
Medical Devices·188 affected·Jun 18, 2024
High RiskFDA
Embecta Corp.
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144...
Medical Devices·185,900 affected·Jun 18, 2024
High RiskFDA
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag...
Drugs·6,874 affected·Jun 17, 2024
High RiskFDA
Roi Cps Llc
Regard Kit containing the Microtek decanter
Medical Devices·78 affected·Jun 17, 2024
High RiskFDA
Pacira Pharmaceuticals Inc
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceutic...
Injectable Drugs·40,517 affected·Jun 12, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Medical Devices·14 affected·Jun 12, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Medical Devices·2 affected·Jun 12, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Medical Devices·35 affected·Jun 12, 2024
High RiskFDA
Canadian Hospital Specialties Ltd.
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Medical Devices·6,300 affected·Jun 11, 2024
High RiskFDA
Microtek Medical Inc.
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Medical Devices·135,999 affected·Jun 3, 2024
High RiskFDA
Stryker Corporation
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood ...
Medical Devices·4 affected·Jun 3, 2024
High RiskFDA
Microtek Medical Inc.
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Medical Devices·30,435 affected·Jun 3, 2024
High RiskFDA
Aspen Surgical
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Medical Devices·1,900 affected·Jun 3, 2024
High RiskFDA
Radiometer Medical Aps
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole bl...
Medical Devices·27,127 affected·May 31, 2024
High RiskFDA
Avanos Medical, Inc.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* ...
Medical Devices·53,384 affected·May 31, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princ...
Injectable Drugs·13,880 affected·May 23, 2024
High RiskFDA
Howmedica Osteonics Corp.
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Medical Devices·209 affected·May 23, 2024
High RiskFDA
Howmedica Osteonics Corp.
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Medical Devices·630 affected·May 23, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Medical Implants·1,198 affected·May 22, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Medical Implants·5,900 affected·May 22, 2024
High RiskFDA
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Medical Implants·5,900 affected·May 22, 2024
High RiskFDA
Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Drugs·3,618,858 affected·May 20, 2024
High RiskFDA
Pfizer Inc.
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intr...
Injectable Drugs·220,400 affected·May 20, 2024
High RiskFDA
Pfizer Inc.
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscul...
Injectable Drugs·84,710 affected·May 20, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Medical Implants·83,511 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Medical Implants·1,379 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Medical Implants·457 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Medical Implants·9,006 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Medical Implants·1,086 affected·May 16, 2024
High RiskFDA
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Medical Implants·8,401 affected·May 16, 2024