Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,559 total recalls
Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural lig
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tu
Ion Beam Applications S.A.
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code
Baxter Healthcare Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Beaver Visitec International, Inc.
SOMATOM Edge Plus-Computed tomography system Model 1026700
Siemens Medical Solutions USA, Inc
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1)
TEI Biosciences, Inc.
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Produ
Alcon Research LLC
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
MEDLINE INDUSTRIES, LP - Northfield
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Boston Scientific Corporation
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int
ROUTE 92 MEDICAL INC
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Descript
Drs Vascular, Inc
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Olympus Corporation of the Americas
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Numb
Boston Scientific Corporation
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary int
Zimmer, Inc.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Howmedica Osteonics Corp.
IDM-MICRO-R. Electrical wheelchair component.
mo-Vis BVBA
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/
MEDLINE INDUSTRIES, LP - Northfield
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Howmedica Osteonics Corp.
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Biomet, Inc.
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25"
Medline Industries, LP
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc.
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende
Steris Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Boston Scientific Corporation
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
CareFusion 303, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Beaver Visitec International, Inc.
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic Perfusion Systems
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M
MEDLINE INDUSTRIES, LP - Northfield
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