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
Hospira Inc.
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Injectable Drugs·325,056 affected·Jan 8, 2013
High RiskFDA
Photomedex, Inc.
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyro...
Surgical Devices·549 affected·Jan 4, 2013
CriticalFDA
Green Valley Drugs
Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Hend...
Injectable Drugs·58 affected·Dec 4, 2012
CriticalFDA
Green Valley Drugs
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office U...
Drugs·1,395 affected·Dec 4, 2012
High RiskFDA
Biomet Spine, Llc
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commerci...
Medical Implants·1,999 affected·Nov 30, 2012
High RiskFDA
The Anspach Effort, Inc.
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with ...
Medical Devices·10 affected·Nov 28, 2012
RecallFDA
Pfizer Inc.
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vi...
Injectable Drugs·10,920 affected·Nov 26, 2012
High RiskFDA
Hospira, Inc.
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Injectable Drugs·145,400 affected·Nov 21, 2012
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices place...
Medical Devices·134 affected·Nov 21, 2012
High RiskFDA
Zimmer, Inc.
COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET...
Medical Devices·23 affected·Nov 19, 2012
High RiskFDA
Biomet, Inc.
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for ap...
Medical Implants·200 affected·Nov 15, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT Th...
Medical Devices·318 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGH...
Medical Devices·195 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGH...
Medical Devices·591 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGH...
Medical Devices·429 affected·Nov 14, 2012
High RiskFDA
Medtronic Navigation, Inc.
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill ...
Surgical Devices·12 affected·Nov 13, 2012
CriticalFDA
Hospira Inc.
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (...
Injectable Drugs·31,326 affected·Nov 8, 2012
CriticalFDA
Hospira Inc.
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lak...
Injectable Drugs·23,315 affected·Nov 8, 2012
High RiskFDA
Medline Industries Inc
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the...
Medical Devices·105 affected·Nov 8, 2012
High RiskFDA
Alkermes, Inc.
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01,...
Injectable Drugs·3,325 affected·Nov 6, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Produ...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70k...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50k...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Pro...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
King Systems Corp.
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Pr...
Medical Devices·263 affected·Nov 2, 2012
High RiskFDA
Ameridose Llc
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be a...
Drugs·0 affected·Oct 31, 2012
High RiskFDA
Ameridose Llc
All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be acces...
Drugs·0 affected·Oct 31, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along sutu...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture line...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Hospira Inc.
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL...
Injectable Drugs·11,412 affected·Oct 22, 2012
High RiskFDA
New England Compounding Center
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on ...
Drugs·0 affected·Oct 6, 2012
High RiskFDA
New England Compounding Center
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found...
Drugs·0 affected·Oct 6, 2012
CriticalFDA
Hospira Inc.
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-79...
Injectable Drugs·136,224 affected·Oct 5, 2012
High RiskFDA
Ethicon Endo-surgery Inc
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Surgical Devices·5,894,975 affected·Oct 4, 2012
RecallFDA
Itw Dymon
Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)]...
Drugs·216 affected·Sep 28, 2012
High RiskFDA
Biomet 3i, Llc
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for...
Medical Implants·76 affected·Sep 28, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, I...
Injectable Drugs·240,550 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 6017...
Injectable Drugs·101,200 affected·Sep 27, 2012
High RiskFDA
Fresenius Kabi Usa, Llc
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumbu...
Injectable Drugs·184,550 affected·Sep 27, 2012
CriticalFDA
New England Compounding Center
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center...
Injectable Drugs·9,062 affected·Sep 26, 2012