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
International Medsurg Connection, Inc.
Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from ...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
Kentec Medical Inc
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y6...
Medical Devices·100,526 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or wit...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject flui...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject flui...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject flui...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, ...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or wit...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or wi...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or w...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
International Medsurg Connection, Inc.
Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, ...
Medical Devices·54,204,100 affected·Jun 23, 2017
High RiskFDA
Advanced Pharma Inc.
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL v...
Injectable Drugs·2,350 affected·Jun 22, 2017
High RiskFDA
Advanced Pharma Inc.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 7705...
Drugs·72 affected·Jun 22, 2017
High RiskFDA
Advanced Pharma Inc.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 7705...
Drugs·0 affected·Jun 22, 2017
High RiskFDA
Advanced Pharma Inc.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 7705...
Drugs·0 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulm...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fi...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia can...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceutica...
Drugs·660 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceut...
Drugs·20 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceutica...
Drugs·20 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuti...
Drugs·221 affected·Jun 21, 2017
High RiskFDA
Fagron Compounding Services Llc Dba Fagron Sterile Services
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC...
Injectable Drugs·1,056 affected·Jun 19, 2017
High RiskFDA
Conmed Corporation
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT...
Surgical Devices·1,612,440 affected·Jun 19, 2017
RecallUSDA
Unknown
Supreme Cuisine Recalls Meat and Poultry Fat and Lard Products Due to Processing Deviation
Beef·0 affected·Jun 17, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·72,575 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·5,100 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·71,825 affected·Jun 16, 2017
High RiskFDA
Hospira A Pfizer Company
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, ...
Drugs·91,483,150 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx ...
Drugs·20,337,650 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-...
Drugs·21,436,700 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: ...
Injectable Drugs·15,034,600 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterili...
Medical Devices·32 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·3 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Tei Biosciences
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to...
Medical Devices·4,081 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·5 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·5 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·139 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·58 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·29 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·78 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·17 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·55 affected·Jun 15, 2017