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
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is us...
Medical Devices·50 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Produc...
Surgical Devices·570 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is use...
Medical Devices·30 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is use...
Medical Devices·2,697 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is us...
Medical Devices·6 affected·Apr 23, 2020
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Medical Devices·18 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is use...
Medical Devices·7,395 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: ...
Medical Devices·1,864 affected·Apr 23, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 1088885...
Medical Implants·211 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
Coopersurgical, Inc.
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Surgical Devices·1,740 affected·Apr 9, 2020
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon O...
Medical Devices·0 affected·Mar 31, 2020
High RiskFDA
Edwards Lifesciences, Llc
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Surgical Devices·597 affected·Mar 27, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MU...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 ...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , C...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Innovative Intrathecal Solutions, Inc. Dba Innovative Compounding Pharmacy
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MU...
Injectable Drugs·0 affected·Mar 26, 2020
High RiskFDA
Becton Dickinson & Company
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403...
Surgical Devices·900 affected·Mar 26, 2020
High RiskFDA
Edge Pharma, Llc
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL ...
Injectable Drugs·48 affected·Mar 19, 2020
High RiskFDA
Edge Pharma, Llc
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECT...
Injectable Drugs·71 affected·Mar 19, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Medical Devices·125,196 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Medical Devices·32,760 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Medical Devices·4,320 affected·Mar 17, 2020
High RiskFDA
Pharmedium Services, Llc
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 7...
Injectable Drugs·2,475 affected·Mar 16, 2020