Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning
Ultra Clean Systems, Inc.
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY,
MEDLINE INDUSTRIES, LP - Northfield
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab
Davol, Inc.
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int
Cordis US Corp
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Ad-Tech Medical Instrument Corporation
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF
Abbott Molecular, Inc.
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline Industries, LP
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod
MEDLINE INDUSTRIES, LP - Northfield
DREAMTOME 49-20MM/260CM Material Number: M00584000
Boston Scientific Corporation
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep
MEDLINE INDUSTRIES, LP - Northfield
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a
Olympus Corporation of the Americas
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR M
MEDLINE INDUSTRIES, LP - Northfield
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile
GE Medical Systems, LLC
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Avanos Medical, Inc.
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device
Olympus Corporation of the Americas
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
IPG Medical Corporation
MOSAIQ Oncology Information System
Elekta, Inc.
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb
Medline Industries, LP
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.
Beaver Visitec International, Inc.
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
AtriCure, Inc.
DeRoyal SPINE PACK, REF 89-8361.08
DeRoyal Industries Inc
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the Li
XENEX Disinfection Services Inc.
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074
Philips North America
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an
Becton Dickinson & Co.
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Olympus Corporation of the Americas
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
SURGICAL SPECIALTIES
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG
Luminex Corporation
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
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