Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 116 of 548
FDA Devices Critical Jun 28, 2023
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Critical Jun 28, 2023
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Critical Jun 28, 2023
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Critical Jun 28, 2023
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jun 28, 2023
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Masimo Corporation
CPSC Moderate Jun 22, 2023
Infanttech Recalls Zooby Video Baby Monitors for Cars Due to Fire Hazard (Recall Alert)
FDA Devices Moderate Jun 21, 2023
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Galt Medical Corporation
FDA Devices Moderate Jun 21, 2023
Eye and Ear Dropper, Product Code 67082
Apothecary Products, LLC
FDA Devices Moderate Jun 21, 2023
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
p-Chip Wand Reader
p-Chip Corporation
FDA Devices Moderate Jun 21, 2023
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
LumiraDx
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Galt Medical Corporation
FDA Devices Moderate Jun 21, 2023
Medicine Dropper, Product Code K508
Apothecary Products, LLC
FDA Devices Low Jun 21, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Datascope Corp.
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, RE…
Ossur H / F
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Critical Jun 21, 2023
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
NOXBOX LTD
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
FDA Devices Moderate Jun 21, 2023
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Super…
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
CPSC Moderate Jun 15, 2023
Huish Recalls Oceanic SCUBA Diving Buoyancy Compensating Devices Due to Drowning Hazard
FDA Devices Moderate Jun 14, 2023
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Avanos Medical, Inc.
FDA Devices Low Jun 14, 2023
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Abbott Ireland Limited
FDA Devices Critical Jun 14, 2023
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU220…
Philips Respironics, Inc.
FDA Devices Moderate Jun 14, 2023
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
C.R. Bard Inc
FDA Devices Moderate Jun 14, 2023
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detec…
Becton Dickinson & Co.
FDA Devices Moderate Jun 14, 2023
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-S…
DeRoyal Industries Inc
FDA Devices Moderate Jun 14, 2023
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Gr…
Bolton Medical Inc.
FDA Devices Moderate Jun 14, 2023
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Avanos Medical, Inc.
FDA Devices Low Jun 14, 2023
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starr…
Mechatronics USA
FDA Devices Moderate Jun 14, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization …
DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Moderate Jun 14, 2023
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
C.R. Bard Inc
FDA Devices Moderate Jun 14, 2023
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Mode…
DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Critical Jun 14, 2023
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B,…
Philips Respironics, Inc.
FDA Devices Moderate Jun 14, 2023
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Cardinal Health 200, LLC
FDA Devices Moderate Jun 14, 2023
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Mod…
DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Critical Jun 14, 2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Medtronic Navigation, Inc.
FDA Devices Moderate Jun 14, 2023
ambIT Cassette Filter Male Luer, Product Code: 220266
Avanos Medical, Inc.
FDA Devices Moderate Jun 14, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization…
DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Low Jun 14, 2023
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Eryt…
Mechatronics USA
FDA Devices Moderate Jun 14, 2023
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jac…
DeRoyal Industries Inc
FDA Devices Critical Jun 14, 2023
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situation…
BearCare, Inc.
FDA Devices Critical Jun 14, 2023
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Medtronic Navigation, Inc.