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
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Tornier, Inc
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Marti...
Medical Implants·20 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Southwest Technologies Inc
Stimulen Collagen Moisturizing Lotion, ST9555B
Medical Devices·2,016 affected·May 28, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using et...
Medical Devices·290 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Medical Devices·1,679 affected·May 26, 2021
High RiskFDA
Smith & Nephew, Inc.
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, F...
Medical Implants·5 affected·May 19, 2021
High RiskFDA
Adria Srl
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Medical Devices·0 affected·May 17, 2021
High RiskFDA
Adria Srl
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Medical Devices·0 affected·May 17, 2021
Medium RiskFDA
Medline Industries Inc
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured...
Drugs·231,936 affected·May 14, 2021
High RiskFDA
W L Gore & Associates, Inc.
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Referen...
Medical Devices·0 affected·May 12, 2021
High RiskFDA
Encore Medical, Lp
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Surgical Devices·10 affected·May 12, 2021
High RiskFDA
Encore Medical, Lp
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Surgical Devices·10 affected·May 12, 2021
CriticalFDA
People's Custom Rx And Clinical Care, Llc
C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, M...
Drugs·14 affected·May 11, 2021
High RiskFDA
Pfizer Inc.
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., ...
Drugs·49,525 affected·May 3, 2021
High RiskFDA
Medline Industries Inc
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, wh...
Medical Devices·36 affected·Apr 30, 2021
High RiskFDA
Covidien, Lp
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and resp...
Respiratory Devices·192,000 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patien...
Respiratory Devices·7,200 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·5 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medical Devices·25 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medical Devices·12 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Medical Devices·8,800 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medical Devices·2 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medical Devices·3 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medical Devices·61 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medical Devices·16 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care ...
Respiratory Devices·32,625 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·1 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medical Devices·8 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medical Devices·26 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medical Devices·18 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·11 affected·Apr 29, 2021
High RiskFDA
Quanta System, S.p.a.
Quanta System Sterile Optical Laser Fiber, reusable
Medical Devices·307 affected·Apr 27, 2021
High RiskFDA
Quanta System, S.p.a.
Olympus Sterile Optical Laser Fiber, single use and reusable
Medical Devices·26,925 affected·Apr 27, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North...
Injectable Drugs·3,150 affected·Apr 26, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Me...
Injectable Drugs·192,277 affected·Apr 26, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0...
Injectable Drugs·3,138 affected·Apr 26, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., Nort...
Injectable Drugs·7,020 affected·Apr 26, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North ...
Injectable Drugs·7,564 affected·Apr 26, 2021