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
Icu Medical, Inc.
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pi...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector i...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Steril...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer,...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rota...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The b...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmona...
Respiratory Devices·10 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiop...
Respiratory Devices·27 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulm...
Respiratory Devices·8 affected·Jul 27, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·6,257 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic ...
Medical Devices·6 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·1,144 affected·Jul 26, 2017
Medium RiskFDA
Teva Pharmaceuticals Usa
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per ...
Drugs·401,750 affected·Jul 25, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
3-Way Standardbore Stopcock. Product Code: AMS-100.
Medical Devices·200 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
Medical Devices·156 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Medical Devices·300 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
Medical Devices·0 affected·Jul 24, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Medical Implants·50 affected·Jul 21, 2017
High RiskFDA
Synthes (usa) Products Llc
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Medical Devices·4 affected·Jul 21, 2017
High RiskFDA
Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Medical Devices·255 affected·Jul 21, 2017
High RiskFDA
Medline Industries Inc
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, ...
Medical Devices·5,722 affected·Jul 18, 2017
High RiskFDA
Vyaire Medical
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, R...
Medical Devices·5,400 affected·Jul 18, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrel...
Drugs·46,078 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell ...
Drugs·49,666 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little...
Injectable Drugs·75,840 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-02...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-08...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 ...
Drugs·120 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell ...
Injectable Drugs·120,856 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, R...
Injectable Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA P...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. L...
Injectable Drugs·28,779 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Con...
Drugs·130 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceutica...
Drugs·108 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Litt...
Injectable Drugs·5,245 affected·Jul 14, 2017