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
Terumo Cardiovascular Systems Corporation
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus ...
Medical Devices·26 affected·Dec 12, 2013
High RiskFDA
Actavis Inc
Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System con...
Injectable Drugs·99 affected·Dec 9, 2013
High RiskFDA
Gambro Renal Products, Incorporated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and...
Medical Devices·306,525 affected·Dec 9, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConn...
Medical Devices·5 affected·Dec 6, 2013
High RiskFDA
Rti Surgical, Inc.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using...
Medical Devices·14 affected·Dec 6, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the ST...
Medical Devices·4,048 affected·Nov 26, 2013
High RiskFDA
Navilyst Medical, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; ...
Medical Implants·920 affected·Nov 25, 2013
High RiskFDA
Smith & Nephew Inc
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, In...
Medical Devices·38 affected·Nov 25, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Lin...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling L...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needl...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blo...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) A...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Lue...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip s...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
CriticalFDA
B. Braun Medical Inc
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile...
Injectable Drugs·22,584 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Steril...
Injectable Drugs·136,392 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single D...
Injectable Drugs·22,248 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine...
Injectable Drugs·1,302 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical I...
Injectable Drugs·17,544 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, ...
Injectable Drugs·18,288 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Do...
Injectable Drugs·18,090 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single d...
Injectable Drugs·4,614 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Ir...
Drugs·5,592 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, ...
Injectable Drugs·32,376 affected·Nov 21, 2013
High RiskFDA
Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Ste...
Medical Devices·6,028 affected·Nov 21, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Bosto...
Medical Devices·253 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device...
Medical Devices·3,300 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Bosto...
Medical Devices·425 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Bost...
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston...
Medical Devices·740 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK -...
Medical Devices·153 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, S...
Medical Devices·45 affected·Nov 20, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·625 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·641 affected·Nov 19, 2013
High RiskFDA
Smith & Nephew Inc.
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Medical Devices·6,871,375 affected·Nov 14, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08...
Cardiac Devices·78 affected·Nov 13, 2013
High RiskFDA
Baxter Healthcare Corp.
10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutr...
Injectable Drugs·14,622 affected·Nov 12, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize...
Medical Devices·4,381 affected·Nov 11, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize he...
Medical Devices·4,381 affected·Nov 11, 2013
High RiskFDA
Glaxosmithkline, Llc.
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sum...
Injectable Drugs·9,743 affected·Nov 6, 2013
High RiskFDA
Glaxosmithkline, Llc.
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatri...
Injectable Drugs·10,469 affected·Nov 6, 2013
High RiskFDA
Boston Scientific Corporation
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in...
Medical Devices·449 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
NGK Stem Ext 24 x 245mm
Medical Devices·42 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
DIST LAT FEM LOCK PLT, RT
Medical Devices·42 affected·Nov 5, 2013