Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,476 records, page 262 of 1190
FDA device recalls, page 262 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0715-2022Class IIMEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032Stryker Leibinger GmbH & Co. KGFTM
Z-0696-2022Class IIMEDLINE Micro-Kill Bleach Germicidal Bleach WipesMEDLINE INDUSTRIES, LP - NorthfieldLRJ
Z-0533-2022Class IIX060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.Xtant Medical Holdings, Inc.PEK
Z-0555-2022Class IIYOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF...Young Dental Manufacturing Co 1, LLC.JOJ
Z-0530-2022Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code...Baxter Healthcare CorporationFRN
Z-0529-2022Class IBaxter Spectrum IQ Infusion Pumps, Product code 3570009.Baxter Healthcare CorporationFRN
Z-0659-2022Class ICelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Celltrion USA IncQKP
Z-0711-2022Class IIBronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is...Hobbs Medical, Inc.FDX
Z-0640-2022Class IILiko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015Hill-Rom Inc.FSA
Z-0639-2022Class IILiko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010Hill-Rom Inc.FSA
Z-0621-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK...GE HealthcareLNH
Z-0620-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s...GE HealthcareLNH
Z-0619-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System...GE HealthcareLNH
Z-0618-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System...GE HealthcareLNH
Z-0617-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx...GE HealthcareLNH
Z-0616-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System...GE HealthcareLNH
Z-0615-2022Class IIGE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System...GE HealthcareLNH
Z-0614-2022Class IIGE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR...GE HealthcareLNH
Z-0613-2022Class IIGE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed...GE HealthcareLNH
Z-0612-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR...GE HealthcareLNH
Z-0611-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355...GE HealthcareLNH
Z-0610-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima...GE HealthcareLNH
Z-0609-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR...GE HealthcareLNH
Z-0608-2022Class IIGE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with...GE HealthcareLNH
Z-0607-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR...GE HealthcareLNH
Z-0606-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR...GE HealthcareLNH
Z-0605-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR...GE HealthcareLNH
Z-0604-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T...GE HealthcareLNH
Z-0603-2022Class IIGE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE...GE HealthcareLNH
Z-0602-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450...GE HealthcareLNH
Z-0601-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w...GE HealthcareLNH
Z-0600-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist...GE HealthcareLNH
Z-0599-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and...GE HealthcareLNH
Z-0598-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380...GE HealthcareLNH
Z-0597-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and...GE HealthcareLNH
Z-0596-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and...GE HealthcareLNH
Z-0595-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR...GE HealthcareOUO
Z-0594-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750...GE HealthcareLNH
Z-0593-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w...GE HealthcareLNH
Z-0592-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer...GE HealthcareLNH
Z-0591-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect...GE HealthcareLNH
Z-0590-2022Class IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier...GE HealthcareLNH
Z-0551-2022Class IISpiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated...OLYMPUS Corporation of the AmericasNJK
Z-0702-2022Class IIda Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11Intuitive Surgical, Inc.NAY
Z-0781-2022Class IIRX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M...Boston Scientific CorporationKNS
Z-0780-2022Class IIRX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381...Boston Scientific CorporationKNS
Z-0779-2022Class IIJAGTOME RX 49-30-450-035 Material Number: M00573030Boston Scientific CorporationKNS
Z-0778-2022Class IIJAGTOME RX 49-30-260-035 Material Number: M00573020Boston Scientific CorporationKNS
Z-0777-2022Class IIJAGTOME RX 49-20-260-035 Material Number: M00573000Boston Scientific CorporationKNS
Z-0776-2022Class IIJAGTOME RX 44-30-450-035 Material Number: M00573070Boston Scientific CorporationKNS