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
Us Endoscopy Group Inc
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corru...
Medical Devices·100 affected·Oct 31, 2014
RecallFDA
Coopersurgical, Inc.
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue f...
Surgical Devices·30 affected·Oct 27, 2014
High RiskFDA
Arthrocare Medical Corporation
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Int...
Medical Devices·23,119 affected·Oct 27, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Dr...
Surgical Devices·120 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral ...
Surgical Devices·90 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, in...
Surgical Devices·83 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introducti...
Surgical Devices·100 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chro...
Surgical Devices·85 affected·Oct 20, 2014
High RiskFDA
Ethicon, Inc.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Medical Devices·2,508 affected·Oct 17, 2014
High RiskFDA
Mallinckrodt Manufacturing Llc
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures...
Surgical Devices·246 affected·Oct 17, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Medical Devices·3,082 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The A...
Medical Implants·10,085 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 724041...
Medical Implants·2,165 affected·Oct 15, 2014
High RiskFDA
Vann Healthcare Services Inc
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare ...
Drugs·7 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·1 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, ...
Injectable Drugs·340,272 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Injectable Drugs·784,920 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
Injectable Drugs·153,504 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Injectable Drugs·16,487,040 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
Injectable Drugs·301,560 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·900 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, N...
Injectable Drugs·823,296 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
Injectable Drugs·6,193,416 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0...
Injectable Drugs·275,448 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045...
Injectable Drugs·305,664 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·410 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL...
Injectable Drugs·152,172 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., La...
Injectable Drugs·836,460 affected·Oct 14, 2014
High RiskFDA
Ad-tech Medical Instrument Corporation
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Elect...
Medical Devices·13 affected·Oct 8, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunct...
Medical Devices·3,138 affected·Oct 8, 2014
High RiskFDA
C.r. Bard, Inc.
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture st...
Medical Devices·86 affected·Oct 7, 2014
High RiskFDA
Zimmer, Inc.
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedur...
Medical Implants·618 affected·Oct 7, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·520 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·12 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·1 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·10 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·540 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·120 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Com...
Drugs·900 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·5 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·119 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·175 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville,...
Injectable Drugs·46 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·2,200 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·900 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, O...
Injectable Drugs·5 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·5 affected·Oct 6, 2014
High RiskFDA
Oregon Compounding Centers, Inc. Dba Creative Compounds
GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Injectable Drugs·40 affected·Oct 6, 2014