Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 172 of 548
FDA Devices Moderate Aug 18, 2021
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Medline Industries Inc
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
Biomet, Inc.
FDA Devices Critical Aug 18, 2021
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Baxter Healthcare Corporation
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewir…
Edwards Lifesciences, LLC
FDA Devices Moderate Aug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidew…
Edwards Lifesciences, LLC
FDA Devices Moderate Aug 18, 2021
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Bard Peripheral Vascular Inc
FDA Devices Moderate Aug 18, 2021
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For t…
Merit Medical Systems, Inc.
FDA Devices Moderate Aug 18, 2021
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric pa…
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Beckman Coulter Inc.
FDA Devices Moderate Aug 18, 2021
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500…
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Aug 18, 2021
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Smith & Nephew Orthopaedics Ltd. (Aurora)
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1…
Beckman Coulter, Inc.
FDA Devices Moderate Aug 18, 2021
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
NEOSTEO
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100
Heartware, Inc.
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Biomet, Inc.
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1104
Heartware, Inc.
FDA Devices Critical Aug 18, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-44…
BioMedical Equipment Service Co (BMES)
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Biomerieux Inc
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Implant Kit, REF 1104JP
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx O…
Merit Medical Systems, Inc.
FDA Devices Critical Aug 18, 2021
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Baxter Healthcare Corporation
FDA Devices Moderate Aug 18, 2021
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
Biomet, Inc.
FDA Devices Moderate Aug 18, 2021
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Richard Wolf GmbH
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100US
Heartware, Inc.
FDA Devices Moderate Aug 18, 2021
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Medtronic Neuromodulation
FDA Devices Moderate Aug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewi…
Edwards Lifesciences, LLC
FDA Drug Moderate Aug 11, 2021
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple T…
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
FDA Devices Moderate Aug 11, 2021
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Tenderneeds Fertility LLC
FDA Devices Moderate Aug 11, 2021
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
ROi CPS LLC
FDA Devices Moderate Aug 11, 2021
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Tenderneeds Fertility LLC
FDA Devices Moderate Aug 11, 2021
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Abbott Laboratories
FDA Devices Moderate Aug 11, 2021
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Tenderneeds Fertility LLC
FDA Devices Low Aug 11, 2021
GlideScope Go Monitors
Verathon, Inc.
FDA Devices Moderate Aug 11, 2021
Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Tenderneeds Fertility LLC
FDA Devices Moderate Aug 11, 2021
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
ROi CPS LLC
FDA Devices Low Aug 11, 2021
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Stanbio Laboratory, LP
FDA Devices Moderate Aug 11, 2021
Sharesource Connectivity Platform for Use with the Amia Automated PD System
BAXTER HEALTHCARE CORPORATION
FDA Devices Moderate Aug 11, 2021
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
ROi CPS LLC
FDA Devices Moderate Aug 11, 2021
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, U…
Abbott Laboratories
FDA Devices Moderate Aug 11, 2021
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Tenderneeds Fertility LLC