Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e)...
Medical Devices·0 affected·Nov 21, 2023
CriticalFDA
Roi Cps Llc
Regard Dressing change kit, Item Number 800026006
Medical Devices·1,830 affected·Nov 20, 2023
CriticalFDA
Resmed Ltd.
AirTouch F20 Full Face Mask and User Guide
Medical Devices·3,816,138 affected·Nov 20, 2023
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Medical Devices·98 affected·Nov 20, 2023
CriticalFDA
Resmed Ltd.
AirTouch N20 Nasal Mask and User Guide
Medical Devices·424,309 affected·Nov 20, 2023
CriticalFDA
Resmed Ltd.
AirFit F30 Full Face Mask and User Guide
Medical Devices·2,660,776 affected·Nov 20, 2023
High RiskFDA
Keystone Industries
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, rep...
Medical Devices·336 affected·Nov 20, 2023
CriticalFDA
Resmed Ltd.
AirFit N10 Nasal Masks and User Guide
Medical Devices·199,796 affected·Nov 20, 2023
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 CAL2351
Medical Devices·269 affected·Nov 20, 2023
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
Medical Devices·61 affected·Nov 20, 2023
High RiskFDA
Steris Corporation
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through ...
Medical Devices·4,214 affected·Nov 16, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Medical Devices·385,028 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Medical Devices·483 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580...
Medical Devices·12,000 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF C...
Medical Devices·11,812 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) ...
Medical Devices·533 affected·Nov 15, 2023
High RiskFDA
Landauer
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Medical Devices·584 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERA...
Medical Devices·2,903 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1,...
Medical Devices·1,270 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
Medical Devices·16 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOS...
Medical Devices·991,744 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700...
Medical Devices·86,699 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c...
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Medical Devices·228 affected·Nov 15, 2023
High RiskFDA
Soclean, Inc
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Medical Devices·2,339,352 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary gra...
Medical Devices·2 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Medical Devices·220 affected·Nov 15, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Medical Devices·339,936 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL...
Medical Devices·1,184 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCP...
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARAC...
Medical Devices·5,724 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF ...
Medical Devices·5,969 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATIO...
Medical Devices·21,154 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Medical Devices·1,260 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; ...
Medical Devices·2,683,387 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
Medical Devices·2,205 affected·Nov 15, 2023
High RiskFDA
Canon Medical System, Usa, Inc.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The syst...
Medical Devices·1 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF ...
Medical Devices·844 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Medical Devices·60 affected·Nov 15, 2023
High RiskFDA
Bard Peripheral Vascular Inc
BD Recanalization System, REF: BDRECANSYSTEM
Medical Devices·403 affected·Nov 14, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medical Devices·98,311 affected·Nov 13, 2023
High RiskFDA
Blue Belt Technologies, Inc
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Medical Devices·1,859 affected·Nov 13, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Medical Devices·78,532 affected·Nov 13, 2023
High RiskFDA
Maquet Medical Systems Usa
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Medical Devices·1,213 affected·Nov 13, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>...
Medical Devices·1,639 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·4,182 affected·Nov 10, 2023