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
Resource Optimization & Innovation Llc
regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·872 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
Medical Devices·114 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible...
Surgical Devices·832 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the l...
Surgical Devices·181 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on...
Surgical Devices·24 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible f...
Surgical Devices·296 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·40 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
Medical Devices·54 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·92 affected·Apr 22, 2015
RecallFDA
Akorn, Inc.
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 ...
Injectable Drugs·370 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Admi...
Medical Devices·50 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: ...
Medical Devices·600 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Bl...
Medical Devices·900 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (Whit...
Medical Devices·1,500 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 ...
Medical Devices·5,100 affected·Apr 20, 2015
High RiskFDA
Medtronic Neuromodulation
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Medical Devices·86,851 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 5000051...
Surgical Devices·4,136 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 57...
Medical Devices·77,588 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Cat...
Surgical Devices·26,108,946 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE ...
Medical Devices·385,486 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7...
Medical Devices·5,786 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581...
Surgical Devices·81,252 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Medical Devices·144 affected·Apr 16, 2015
High RiskFDA
Covidien Llc
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Medical Devices·5,160 affected·Apr 16, 2015
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-71...
Injectable Drugs·128,050 affected·Apr 7, 2015
CriticalFDA
Origen Biomedical, Inc.
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC cathete...
Surgical Devices·134 affected·Mar 30, 2015
High RiskFDA
Biomerieux Inc
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in cli...
Medical Devices·43,535 affected·Mar 27, 2015
High RiskFDA
Biomerieux Inc
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clin...
Medical Devices·1,604 affected·Mar 27, 2015
RecallFDA
Stryker Instruments Div. Of Stryker Corporation
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide po...
Surgical Devices·223 affected·Mar 25, 2015
High RiskFDA
Baxter Healthcare Corp
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL ,...
Injectable Drugs·196,128 affected·Mar 23, 2015
High RiskFDA
Baxter Healthcare Corp
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container,...
Injectable Drugs·7,444 affected·Mar 23, 2015
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT61...
Medical Devices·8,269 affected·Mar 23, 2015
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, I...
Medical Devices·5,125 affected·Mar 23, 2015
High RiskFDA
Baxter Healthcare Corp.
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Caro...
Injectable Drugs·48,874 affected·Mar 18, 2015
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, N...
Injectable Drugs·597,498 affected·Mar 18, 2015
High RiskFDA
American Catheter Corp
American Catheter / Cholangiogram Catheter 9100 Series.
Surgical Devices·890 affected·Mar 17, 2015
High RiskFDA
Vital Signs Colorado Inc.
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Medical Devices·399 affected·Mar 13, 2015
CriticalFDA
Hospira Inc.
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 040...
Drugs·24,744 affected·Mar 11, 2015
High RiskFDA
Microtek Medical Inc
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are i...
Surgical Devices·30,796 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to ev...
Surgical Devices·9,168 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended...
Surgical Devices·3,180 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX I...
Surgical Devices·303 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accesso...
Surgical Devices·5,889 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intende...
Surgical Devices·32,496 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: ...
Surgical Devices·270 affected·Mar 10, 2015
High RiskFDA
Bacterin International, Inc.
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in th...
Medical Devices·63 affected·Mar 9, 2015
High RiskFDA
In2bones, Sas
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Medical Implants·15 affected·Mar 9, 2015
High RiskFDA
Hospira Inc.
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (...
Injectable Drugs·94,440 affected·Mar 5, 2015