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
Ben Venue Laboratories Inc
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146,...
Injectable Drugs·7,172 affected·Jul 31, 2014
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Injectable Drugs·157,080 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·0 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·497 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·1,127 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·66 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·400 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orth...
Medical Devices·9 affected·Jul 30, 2014
High RiskFDA
Integra York Pa, Inc
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container ...
Medical Devices·84 affected·Jul 30, 2014
High RiskFDA
Wright Medical Technology, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Medical Devices·50 affected·Jul 30, 2014
High RiskFDA
Galt Medical Corporation
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to intr...
Surgical Devices·11,155 affected·Jul 25, 2014
High RiskFDA
Galt Medical Corporation
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in ...
Surgical Devices·11,155 affected·Jul 25, 2014
CriticalFDA
Physician Preferred Medical, Llc
Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Pat...
Drugs·122 affected·Jul 24, 2014
High RiskFDA
Zimmer, Inc.
4.5 mm Malleolar Screw Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX...
Medical Devices·972,125 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Medical Devices·972,125 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44M...
Medical Devices·972,125 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & ...
Medical Devices·972,125 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Medical Devices·47,682 affected·Jul 22, 2014
High RiskFDA
Zimmer, Inc.
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG ...
Medical Devices·972,125 affected·Jul 22, 2014
High RiskFDA
Unique Pharmaceutical, Ltd
All sterile products within expiry
Drugs·325,225 affected·Jul 18, 2014
CriticalFDA
Unique Pharmaceutical, Ltd
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Drugs·3,529 affected·Jul 18, 2014
CriticalFDA
Cook Inc.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in...
Surgical Devices·696 affected·Jul 17, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter...
Medical Devices·234,196 affected·Jul 14, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Lu...
Medical Devices·11,184 affected·Jul 14, 2014
CriticalFDA
Baxter Healthcare Corp.
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfiel...
Injectable Drugs·171,672 affected·Jul 11, 2014
CriticalFDA
Hospira Inc.
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-...
Injectable Drugs·142,644 affected·Jul 10, 2014
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded w...
Diagnostic Devices·1,045 affected·Jul 9, 2014
High RiskFDA
Richard Wolf Medical Instruments Corp.
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray...
Medical Devices·73 affected·Jul 9, 2014
High RiskFDA
Smith & Nephew, Inc.
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) I...
Medical Devices·601 affected·Jul 2, 2014
High RiskFDA
Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to...
Medical Implants·190 affected·Jul 1, 2014
High RiskFDA
Zimmer, Inc.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to...
Medical Implants·190 affected·Jul 1, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--N...
Drugs·0 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Feder...
Drugs·50 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not...
Drugs·48 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Feder...
Drugs·220 affected·Jun 27, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutio...
Drugs·12 affected·Jun 27, 2014
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lak...
Injectable Drugs·47,400 affected·Jun 27, 2014
High RiskFDA
Medical Supply Liquidators Llc
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunsh...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: ...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc....
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB In...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial...
Injectable Drugs·0 affected·Jun 25, 2014
High RiskFDA
Medical Supply Liquidators Llc
L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc...
Injectable Drugs·0 affected·Jun 25, 2014