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
Sandoz Inc
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758...
Injectable Drugs·1,584 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758...
Injectable Drugs·32,099 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pa...
Surgical Devices·18 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek p...
Surgical Devices·14 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged...
Medical Devices·1 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch,...
Surgical Devices·10 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyve...
Medical Devices·9 affected·Aug 23, 2016
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cav...
Medical Implants·25 affected·Aug 16, 2016
High RiskFDA
Deroyal Industries Inc
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Surgical Devices·26 affected·Aug 11, 2016
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Surgical Devices·24 affected·Aug 11, 2016
High RiskFDA
Global Healthcare Inc
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientifi...
Medical Devices·282 affected·Aug 9, 2016
High RiskFDA
Biomet 3i, Llc
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Medical Implants·92 affected·Aug 8, 2016
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Medical Devices·1,788,150 affected·Aug 8, 2016
High RiskFDA
Riverpoint Medical, Llc
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 6...
Surgical Devices·2,110 affected·Aug 5, 2016
High RiskFDA
Riverpoint Medical, Llc
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general ...
Surgical Devices·61 affected·Aug 5, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Medical Devices·200 affected·Aug 4, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design...
Surgical Devices·0 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is avail...
Surgical Devices·452,728 affected·Aug 3, 2016
High RiskFDA
Lemaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is int...
Medical Devices·380 affected·Aug 3, 2016
High RiskFDA
Lemaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the t...
Medical Devices·1,992 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc...
Surgical Devices·0 affected·Aug 3, 2016
High RiskFDA
C.r. Bard, Inc.
BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a ...
Surgical Devices·0 affected·Aug 3, 2016
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·535 affected·Aug 2, 2016
High RiskFDA
Best Sanitizers Inc
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set ...
Medical Devices·3,023 affected·Aug 2, 2016
High RiskFDA
Isomeric Pharmacy Solution, Llc
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isom...
Injectable Drugs·2,331 affected·Aug 1, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembl...
Medical Implants·2,039 affected·Aug 1, 2016
High RiskFDA
B. Braun Medical, Inc.
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Medical Devices·15,950 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Produ...
Surgical Devices·114,081 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product ...
Surgical Devices·47,989 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Produc...
Surgical Devices·78,063 affected·Jul 29, 2016
High RiskFDA
Colonia Care Pharmacy
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Drugs·0 affected·Jul 28, 2016
High RiskFDA
Colonia Care Pharmacy
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Drugs·0 affected·Jul 28, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·23 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·36 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Drugs·139 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·5 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tet...
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain...
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·8 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·62 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·108 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·14 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5....
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67...
Ophthalmic Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compou...
Injectable Drugs·3 affected·Jul 26, 2016