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
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Cardiac Devices·90 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Medical Devices·388 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Medical Devices·237 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO , Model No SACY80R
Medical Devices·144 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Medical Devices·1,200 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Medical Devices·1,836 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Medical Devices·48 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO PACK , Model N. HKCY31A
Medical Devices·36 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
BORN ON ARRIVAL KIT , Model No LLBN11B
Medical Devices·54 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Medical Devices·41 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Medical Devices·956 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Medical Devices·1,106 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
AV FISTULA , Model No UTAV77T
Medical Devices·90 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Medical Devices·40 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Medical Devices·91 affected·Feb 4, 2025
High RiskFDA
Fagron Compounding Services
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St ...
Injectable Drugs·1,330 affected·Jan 31, 2025
High RiskFDA
American Contract Systems, Inc.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/...
Cardiac Devices·460 affected·Jan 31, 2025
High RiskFDA
American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Compone...
Medical Devices·800 affected·Jan 31, 2025
High RiskFDA
Stryker Corporation
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Medical Devices·9,521 affected·Jan 29, 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·118,104 affected·Jan 23, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Medical Devices·30,000 affected·Jan 9, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: ...
Medical Devices·50,000 affected·Jan 9, 2025
High RiskFDA
Xtant Medical Holdings, Inc
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X0...
Medical Devices·14 affected·Jan 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Medical Devices·36 affected·Jan 3, 2025
High RiskFDA
Ethicon, Llc
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxi...
Surgical Devices·15,948 affected·Dec 20, 2024
High RiskFDA
Ethicon, Llc
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Medical Devices·48 affected·Dec 20, 2024
High RiskFDA
Hikma Injectables Usa Inc
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road...
Injectable Drugs·1,800 affected·Dec 19, 2024
High RiskFDA
Hikma Injectables Usa Inc
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08...
Injectable Drugs·0 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Medical Devices·1,510 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Medical Devices·221 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·59 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·185 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Medical Devices·185 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Medical Devices·39 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·65 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·180 affected·Dec 19, 2024
CriticalFDA
Alcon Research Llc
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Ophthalmic Drugs·55,960 affected·Dec 18, 2024
High RiskFDA
Fdc Limited
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairf...
Ophthalmic Drugs·136,181 affected·Dec 16, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software ...
Medical Devices·5,940 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Ver...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Ca...
Medical Devices·3,960 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Numb...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Tree House Foods Inc
Great Value, Chicken Broth, 48 oz. , Aseptic paper cartons, 6 retail units per case, 120 cases/pallet .
Meat & Poultry·2,023 affected·Dec 11, 2024
High RiskFDA
Microvention Inc.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended p...
Medical Implants·11 affected·Dec 11, 2024
High RiskFDA
Hf Acquisition Co Llc
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring Syste...
Medical Devices·4,021 affected·Dec 11, 2024
High RiskFDA
Regenerative Processing Plant, Llc
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerati...
Ophthalmic Drugs·170,812 affected·Dec 10, 2024
High RiskFDA
Regenerative Processing Plant, Llc
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: R...
Ophthalmic Drugs·59,275 affected·Dec 10, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharash...
Ophthalmic Drugs·5,184 affected·Dec 5, 2024