Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Boston Scientific Corporation
IntelliSpace Cardiovascular, Software 8.0.0.4.
Philips Medical Systems Nederland B.V.
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Stradis Medical, LLC dba Stradis Healthcare
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptoco
Hologic, Inc
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Shimadzu Medical Systems
LOCAL PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
DeRoyal PEDI ORTHO PACK, REF 89-5323.20
DeRoyal Industries Inc
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Olympus Corporation of the Americas
Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A
Alcon Research LLC
Alinity hq Analyzer, REF: 09P68-01
Abbott Laboratories
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
GE Medical Systems, SCS
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Aesculap Implant Systems LLC
CoolSeal Generator, REF: CSL-200-50
Bolder Surgical, LLC
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl
Centerline Biomedical Inc
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Siemens Healthcare Diagnostics, Inc.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper IGTS Fixed Systems
Philips North America
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050,
ETAC A/S
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
ARROW INTERNATIONAL Inc.
Philips C5-2 Transducer.
Philips Ultrasound, Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to
Siemens Healthcare Diagnostics Inc
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient
Megadyne Medical Products, Inc.
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Baxter Healthcare Corporation
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
Remel Inc
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips North America Llc
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
Medline Industries, LP
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Masimo Corporation
HENRY SCHEIN, Vas Pack, Item No.888-2520,
Stradis Medical, LLC dba Stradis Healthcare
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w
MEDLINE INDUSTRIES, LP - Northfield
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