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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 763 of 1190

FDA device recalls, page 763 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1380-2013	Class II	UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE...	Orthopedic Alliance, LLC	JWH	2013-02-20
Z-1379-2013	Class II	Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial...	Orthopedic Alliance, LLC	JWH	2013-02-20
Z-1378-2013	Class II	Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2...	Orthopedic Alliance, LLC	JWH	2013-02-20
Z-1409-2013	Class II	45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of...	Spinal Solutions, LLC	MNI	2013-02-20
Z-0921-2013	Class II	3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical...	Genesys Spine	KWQ	2013-02-20
Z-0484-2014	Class II	Helion S Exam Light or H300 The device is intended to locally illuminate an examination...	Hill-Rom Inc.	FSY	2013-02-19
Z-1560-2013	Class II	Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch...	Tecan U.S.	JQW	2013-02-19
Z-1962-2013	Class III	Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each...	Remel Inc	GNX	2013-02-19
Z-0908-2013	Class II	Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary...	Medtronic, Inc.	DWF	2013-02-19
Z-1016-2017	Class II	Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use...	Abbott Medical	FPK	2013-02-19
Z-1129-2014	Class II	Punch Hair Matic A surgical hair transplant device designed for automation of follicular...	Medicamat S.A.	GEY	2013-02-18
Z-1214-2015	Class II	The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis...	GE Healthcare	LLZ	2013-02-18
Z-2300-2016	Class II	Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product...	GE Healthcare	LLZ	2013-02-18
Z-1782-2017	Class II	Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a...	GE Healthcare	LLZ	2013-02-18
Z-0991-2013	Class II	VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC...	bioMerieux, Inc.	LTW	2013-02-18
Z-0990-2013	Class II	VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC...	bioMerieux, Inc.	LTW	2013-02-18
Z-0989-2013	Class II	VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC...	bioMerieux, Inc.	LTW	2013-02-18
Z-1419-2013	Class II	RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0...	RaySearch Laboratories AB (publ)	MUJ	2013-02-15
Z-1347-2013	Class II	PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the...	Unimed Surgical Products, Inc.	GEI	2013-02-15
Z-1343-2013	Class II	Molift Smart 150	Etac A/S	FSA	2013-02-15
Z-1342-2013	Class II	Molift Smart 150	Etac A/S	FSA	2013-02-15
Z-0950-2013	Class II	Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and...	Philips North America LLC	JAK	2013-02-15
Z-1050-2013	Class III	ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System...	Horiba Instruments Incorporated	JQP	2013-02-15
Z-1143-2013	Class II	Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon...	Elana, Inc.	MCW	2013-02-14
Z-1056-2013	Class III	BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75...	Becton Dickinson & Co	FMH	2013-02-14
Z-1546-2013	Class II	Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is...	Zimmer GmbH	HST	2013-02-14
Z-1060-2013	Class II	Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the...	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	KHE	2013-02-12
Z-1102-2013	Class II	Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal...	Philips North America LLC	JAK	2013-02-12
Z-1059-2013	Class II	Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid...	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	KHE	2013-02-12
Z-0915-2013	Class II	AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and...	STERIS Corporation	FLE	2013-02-12
Z-0886-2013	Class II	Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic...	Integra LifeSciences Corporation	KNF	2013-02-12
Z-1035-2013	Class II	UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-12
Z-1034-2013	Class II	Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-12
Z-1033-2013	Class II	Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-12
Z-1032-2013	Class II	Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems...	Siemens Healthcare Diagnostics Inc.	JJE	2013-02-12
Z-0890-2013	Class II	Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional...	Sonoma Pharmaceuticals, Inc.	FRO	2013-02-12
Z-1021-2013	Class II	Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium...	Microbiologics, Inc.	LJG	2013-02-11
Z-1063-2013	Class II	Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm...	Medtronic, Inc.	GDW	2013-02-11
Z-0927-2013	Class II	ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package...	Genbio	LSR	2013-02-11
Z-0841-2013	Class II	Monaco RTP System. Radiation treatment planning.	Elekta Limited	MUJ	2013-02-11
Z-0178-2018	Class II	ROSA Surgical Device 2.5.8	Zimmer GmbH	HAW	2013-02-10
Z-1191-2013	Class I	Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and...	Medtronic Neuromodulation	MRU	2013-02-08
Z-1096-2013	Class II	GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with...	GE Healthcare	IYN	2013-02-08
Z-1045-2013	Class II	Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or...	Zimmer GmbH	HRX	2013-02-08
Z-1215-2013	Class II	BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124...	Becton Dickinson & Co	JTY	2013-02-08
Z-1190-2013	Class I	Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391...	Medtronic Neuromodulation	MHY	2013-02-08
Z-1082-2013	Class II	The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers...	Physio Control, Inc.	MKJ	2013-02-08
Z-0876-2013	Class III	Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic...	Ultradent Products Inc.	EJF	2013-02-08
Z-1108-2013	Class II	VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-02-07
Z-1107-2013	Class II	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-02-07