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
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthropl...
Medical Devices·0 affected·Mar 17, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthropla...
Medical Devices·0 affected·Mar 17, 2016
Medium RiskFDA
Actavis Pharma Inc
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophtha...
Topical Drugs·447,150 affected·Mar 16, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Pol...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories,...
Injectable Drugs·1,320 affected·Mar 14, 2016
RecallFDA
Lupin Pharmaceuticals Inc.
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New In...
Drugs·741 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG...
Medical Implants·24 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG...
Medical Implants·15 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics ...
Medical Implants·1 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG...
Medical Implants·22 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics ...
Medical Implants·34 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics...
Medical Implants·1 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics A...
Medical Implants·3 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedic...
Medical Implants·6 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics...
Medical Implants·6 affected·Mar 11, 2016
High RiskFDA
Repro-med Systems, Inc.
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Medical Devices·0 affected·Mar 10, 2016
High RiskFDA
Repro-med Systems, Inc.
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, R...
Medical Devices·0 affected·Mar 10, 2016
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 04...
Injectable Drugs·3,342 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Medical Devices·372,480 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
Medical Devices·350,550 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
Medical Devices·2,418,560 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
Medical Devices·36,040 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
Medical Devices·199,488 affected·Mar 3, 2016
High RiskFDA
Dynarex Corporation
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for ...
Medical Devices·399 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
Medical Devices·996,002 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Medical Devices·28,085 affected·Mar 3, 2016
High RiskFDA
Karl Storz Endovision, Inc.
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Numb...
Medical Devices·16,908 affected·Feb 29, 2016
High RiskFDA
Medtronic Navigation, Inc.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Ki...
Surgical Devices·4 affected·Feb 22, 2016
High RiskFDA
Genzyme Corporation
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carto...
Injectable Drugs·4,669 affected·Feb 16, 2016
High RiskFDA
Walter's Pharmacy
Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
Drugs·4 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
Drugs·3 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown,...
Drugs·5 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Drugs·22 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-470...
Drugs·2 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
Drugs·1 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69...
Drugs·4 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
Drugs·5 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Drugs·1 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
Drugs·1 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
Drugs·3 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
Drugs·1 affected·Feb 12, 2016
High RiskFDA
Walter's Pharmacy
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Drugs·2 affected·Feb 12, 2016
High RiskFDA
Alcon Research, Ltd.
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Us...
Ophthalmic Drugs·12,648 affected·Feb 9, 2016
High RiskFDA
Medtronic Neuromodulation
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Surgical Devices·9 affected·Feb 9, 2016
High RiskFDA
Volcano Corporation
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that i...
Surgical Devices·1,355 affected·Feb 5, 2016
High RiskFDA
Volcano Corporation
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment t...
Surgical Devices·1,355 affected·Feb 5, 2016
High RiskFDA
Hartley Medical Center Pharmacy, Incorporated
Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Drugs·1 affected·Feb 4, 2016