Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medical Devices·10 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medical Devices·15 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medical Devices·6 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Medical Devices·500 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·1 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Medical Devices·3,000 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medical Devices·8 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medical Devices·26 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medical Devices·14 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Medical Devices·36,000 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medical Devices·18 affected·Apr 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medical Devices·11 affected·Apr 29, 2021
High RiskFDA
Exact Medical Manufacturing, Inc.
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Medical Devices·7,920 affected·Apr 29, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chron...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment...
Medical Devices·10 affected·Apr 28, 2021
High RiskFDA
Randox Laboratories Ltd.
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Medical Devices·50 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dial...
Medical Devices·1 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock...
Medical Devices·5 affected·Apr 28, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home...
Medical Devices·6 affected·Apr 28, 2021
High RiskFDA
Quanta System, S.p.a.
Quanta System Sterile Optical Laser Fiber, reusable
Medical Devices·307 affected·Apr 27, 2021
High RiskFDA
Quanta System, S.p.a.
Olympus Sterile Optical Laser Fiber, single use and reusable
Medical Devices·26,925 affected·Apr 27, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and p...
Medical Devices·162 affected·Apr 27, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Medical Devices·3 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Medical Devices·4 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Medical Devices·8 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Medical Devices·10 affected·Apr 26, 2021
High RiskFDA
Meta C.g.m. Spa
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Medical Devices·1,692 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Medical Devices·5 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Medical Devices·18 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Medical Devices·8 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Medical Devices·26 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Medical Devices·1 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
Medical Devices·0 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
Medical Devices·7 affected·Apr 26, 2021
High RiskFDA
Meta C.g.m. Spa
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Medical Devices·27 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
Medical Devices·6 affected·Apr 26, 2021
High RiskFDA
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Medical Devices·1 affected·Apr 26, 2021
High RiskFDA
Synaptive Medical Inc
Synaptive Trackable Suction Set Standard and Malleable
Medical Devices·1,291 affected·Apr 23, 2021
High RiskFDA
Coopersurgical, Inc.
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not m...
Medical Devices·6 affected·Apr 23, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Medical Devices·318 affected·Apr 22, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8...
Medical Devices·13,722 affected·Apr 21, 2021
High RiskFDA
Potomac River Group, Corp.
RAPTAR Laser Range Finders
Medical Devices·62 affected·Apr 21, 2021
High RiskFDA
Dentech Corp.
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Medical Devices·87,842 affected·Apr 21, 2021
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide o...
Medical Devices·108 affected·Apr 21, 2021