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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 734 of 1191

FDA device recalls, page 734 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0835-2014	Class II	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF...	DeRoyal Industries, Inc.	ILO	2013-09-17
Z-0834-2014	Class II	Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal...	DeRoyal Industries, Inc.	ILO	2013-09-17
Z-1926-2014	Class II	Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I...	Siemens Healthcare Diagnostics Inc.	JIT	2013-09-17
Z-0009-2014	Class I	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure...	GE Healthcare	BSZ	2013-09-16
Z-0084-2014	Class I	PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I...	PENTAX of America, Inc.	FCX	2013-09-16
Z-2302-2013	Class II	NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model...	Medtronic, Inc.	LOX	2013-09-16
Z-0260-2014	Class II	Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0259-2014	Class II	Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0258-2014	Class II	Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0257-2014	Class II	Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0256-2014	Class II	Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0255-2014	Class II	Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0254-2014	Class II	Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0253-2014	Class II	Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0252-2014	Class II	Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0251-2014	Class II	Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0250-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0249-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0248-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0247-2014	Class II	Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0246-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0245-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0244-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0243-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0242-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0241-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0240-2014	Class II	Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0239-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0238-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0237-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0236-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0235-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0234-2014	Class II	Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0233-2014	Class II	Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0232-2014	Class II	Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0231-2014	Class II	Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0230-2014	Class II	Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0229-2014	Class II	Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0228-2014	Class II	Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0227-2014	Class II	Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0226-2014	Class II	Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0225-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0224-2014	Class II	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0223-2014	Class II	Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0222-2014	Class II	Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0221-2014	Class II	Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0220-2014	Class II	Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an...	Eastman Kodak Company	LLZ	2013-09-16
Z-0219-2014	Class II	Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0218-2014	Class II	Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0217-2014	Class II	Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16