Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.
Smiths Medical ASD, Inc.
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Hamilton Medical, Inc.
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. Fo
Surgical Innovations Ltd
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
ARROW INTERNATIONAL Inc.
Model Number L221 PROPONENT DR EL Pacemaker
Boston Scientific Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;
Beaver Visitec International, Inc.
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Medacta Usa Inc
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK,
Medline Industries, LP
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize
Tandem Diabetes Care, Inc.
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Sonendo Inc
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w
Globus Medical, Inc.
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model number
MEDLINE INDUSTRIES, LP - SPT
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource
Cardinal Health 200, LLC
PhenoMATRIX
Copan WASP
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
CoreLink LLC
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an
Becton Dickinson & Co.
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Philips North America Llc
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractur
Synthes (USA) Products LLC
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in v
Diagnostica Stago, Inc.
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco re
Kinova Inc
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
MEDLINE INDUSTRIES, LP - Northfield
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as
Landauer
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline K
Medline Industries, LP
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Beckman Coulter, Inc.
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mo
Medtronic Neuromodulation
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Howmedica Osteonics Corp.
Medicine Dropper, Product Code K508
Apothecary Products, LLC
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Philips North America
DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
DeRoyal Industries Inc
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
MEDLINE INDUSTRIES, LP - Northfield
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