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
Steris Corporation
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·4 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·39 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·1 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·32 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterili...
Medical Devices·19 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·9 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·8 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·50 affected·Jun 15, 2017
High RiskFDA
Zimmer Biomet, Inc.
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Medical Devices·1,524 affected·Jun 12, 2017
High RiskFDA
Advanced Pharma Inc.
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY ...
Drugs·550 affected·Jun 9, 2017
CriticalFDA
Advanced Pharma Inc.
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FOR...
Drugs·320 affected·Jun 9, 2017
High RiskFDA
Advanced Pharma Inc.
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes ...
Drugs·50 affected·Jun 9, 2017
High RiskFDA
Advanced Pharma Inc.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY F...
Drugs·4,800 affected·Jun 9, 2017
CriticalFDA
Advanced Pharma Inc.
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY ...
Drugs·50 affected·Jun 9, 2017
High RiskFDA
Advanced Pharma Inc.
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FOR...
Drugs·680 affected·Jun 9, 2017
CriticalFDA
Advanced Pharma Inc.
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY F...
Drugs·550 affected·Jun 9, 2017
High RiskFDA
Sorin Group Usa, Inc.
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for us...
Medical Devices·105,770 affected·Jun 9, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty proc...
Surgical Devices·426 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manu...
Medical Devices·17,280 affected·Jun 5, 2017
High RiskFDA
Medpark Pharmacy, Llc
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
Injectable Drugs·1 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Master & Frank (pinghu) Co., Ltd.
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit w...
Surgical Devices·2,160 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
Medical Devices·5,188 affected·Jun 1, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rota...
Surgical Devices·100 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, ste...
Surgical Devices·1,100 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Prod...
Surgical Devices·120 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a...
Surgical Devices·50 affected·May 30, 2017
High RiskFDA
Creganna Medical Devices
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Medical Devices·100 affected·May 22, 2017
High RiskFDA
Creganna Medical Devices
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Medical Devices·50 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
Surgical Devices·224 affected·May 22, 2017
High RiskFDA
Medacta Usa Inc
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Medical Devices·4 affected·May 19, 2017
High RiskFDA
Sca Pharmaceuticals
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preser...
Injectable Drugs·240 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone ...
Injectable Drugs·87 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 1...
Injectable Drugs·56 affected·May 18, 2017