FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 161–180 of 1,000 recalls

Class IIIOngoing

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Datascope Corp.

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

May 4, 2023 · DeviceView details →

Class IIIOngoing

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Abbott Ireland Limited

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

April 24, 2023 · DeviceView details →

FDA Device Recalls

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Total Knee Pack, REF CETJ130, medical convenience kits

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577

RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001