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
Biomet, Inc.
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, ...
Medical Devices·0 affected·Nov 25, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices ...
Cardiac Devices·58,438 affected·Nov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are u...
Cardiac Devices·0 affected·Nov 20, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Surgical Devices·1,566 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Surgical Devices·1,231 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Surgical Devices·748 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Surgical Devices·1,447 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Surgical Devices·651 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Surgical Devices·531 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Surgical Devices·1,337 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Surgical Devices·1,142 affected·Nov 19, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714...
Medical Implants·219 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714...
Medical Implants·319 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714...
Medical Implants·302 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 0871472...
Medical Implants·386 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 0871472...
Medical Implants·278 affected·Nov 17, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25...
Respiratory Devices·5,079 affected·Nov 11, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The...
Surgical Devices·90 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angi...
Cardiac Devices·80 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/a...
Surgical Devices·42 affected·Nov 10, 2020
High RiskFDA
Cryolife, Inc.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the in...
Cardiac Devices·3 affected·Nov 10, 2020
High RiskFDA
Medline Industries Inc
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Produ...
Medical Devices·15,780 affected·Nov 5, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mf...
Injectable Drugs·2,100,646 affected·Nov 3, 2020
High RiskFDA
Boston Scientific Corporation
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter...
Surgical Devices·90 affected·Nov 3, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe t...
Surgical Devices·15 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe...
Surgical Devices·3 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, dispos...
Surgical Devices·37 affected·Oct 12, 2020
High RiskFDA
Microbiologics Inc
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance ...
Diagnostic Devices·46 affected·Oct 8, 2020
CriticalFDA
Med Shop Total Care Inc.
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-...
Injectable Drugs·42 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/M...
Injectable Drugs·84 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-1...
Injectable Drugs·126 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/M...
Injectable Drugs·466 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Injectable Drugs·41 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG...
Injectable Drugs·360 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview,...
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop ...
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longvi...
Injectable Drugs·41 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop ...
Injectable Drugs·21 affected·Oct 5, 2020
CriticalFDA
Med Shop Total Care Inc.
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Lo...
Injectable Drugs·21 affected·Oct 5, 2020
RecallFDA
Xtant Medical
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ ...
Medical Devices·508 affected·Sep 30, 2020
High RiskFDA
Merz North America, Inc.
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of ca...
Medical Implants·2,051 affected·Sep 30, 2020
RecallFDA
Leadiant Biosciences, Inc.
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharma...
Ophthalmic Drugs·1,380 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-806...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
Medical Devices·412 affected·Sep 24, 2020