Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 171 of 548
FDA Devices Moderate Aug 25, 2021
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell Ltd.
FDA Devices Moderate Aug 25, 2021
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW…
Tornier S.A.S.
FDA Devices Low Aug 25, 2021
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Cell Marque Corporation
FDA Devices Moderate Aug 25, 2021
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e)…
Teleflex Medical Europe Ltd
FDA Devices Moderate Aug 25, 2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: …
W L Gore & Associates, Inc.
FDA Devices Moderate Aug 25, 2021
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Philips Respironics, Inc.
FDA Drug Critical Aug 18, 2021
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/M…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) …
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
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/ML, c) 5MG/ML…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
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
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
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/ML, d) 6MG-…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
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 Total Care 4…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview…
Med Shop Total Care Inc.
FDA Drug Critical Aug 18, 2021
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 7…
Med Shop Total Care Inc.
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1125
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 11050000…
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used thro…
Shent USA, Inc.
FDA Devices Moderate Aug 18, 2021
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿27…
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis sc…
Abbott Laboratories, Inc
FDA Devices Moderate Aug 18, 2021
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and…
BioMerieux SA
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working …
Shent USA, Inc.
FDA Devices Moderate Aug 18, 2021
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Medline Industries Inc
FDA Devices Moderate Aug 18, 2021
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platfor…
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspira…
Bard Peripheral Vascular Inc
FDA Devices Moderate Aug 18, 2021
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical trea…
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1153
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3…
Stryker Medical Division of Stryker Corporation
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model …
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surg…
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Exactech, Inc.
FDA Devices Moderate Aug 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Exactech, Inc.
FDA Devices Moderate Aug 18, 2021
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Beckman Coulter Inc.
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (…
Edwards Lifesciences, LLC
FDA Devices Moderate Aug 18, 2021
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
Dutch Ophthalmic USA, Inc.
FDA Devices Moderate Aug 18, 2021
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Beckman Coulter Inc.
FDA Devices Moderate Aug 18, 2021
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002…
Stryker Medical Division of Stryker Corporation