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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 668 of 1191

FDA device recalls, page 668 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1008-2015	Class I	MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A...	Teleflex Medical	BYD	2014-12-04
Z-0938-2015	Class II	Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027...	DSM Biomedical, Inc.	KNW	2014-12-04
Z-0937-2015	Class II	Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505...	DSM Biomedical, Inc.	KNW	2014-12-04
Z-0879-2015	Class II	ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx...	Medtronic, Inc.	NIM	2014-12-04
Z-0878-2015	Class II	ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx...	Medtronic, Inc.	NIM	2014-12-04
Z-0871-2015	Class II	Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow...	Baxter Corporation Englewood	KYX	2014-12-04
Z-0853-2015	Class II	Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach...	Zimmer GmbH	JWH	2014-12-04
Z-0896-2015	Class II	Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint...	Hansen Medical, Inc.	DXX	2014-12-04
Z-0875-2015	Class II	Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is...	Zimmer Manufacturing B.V.	LPH	2014-12-04
Z-1218-2015	Class II	TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care...	Arjohuntleigh AB	IKZ	2014-12-03
Z-1217-2015	Class II	Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care...	Arjohuntleigh AB	IKZ	2014-12-03
Z-1022-2015	Class II	VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only)...	Innokas Medical Oy	MWI	2014-12-03
Z-0952-2015	Class II	POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor...	Medtronic Sofamor Danek USA Inc	HWE	2014-12-03
Z-0972-2015	Class II	Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis...	Siemens Medical Solutions USA, Inc.	OWB	2014-12-03
Z-0995-2015	Class II	Ferno Model 35X PROFlexx Stretchers, one unit per package	Ferno-Washington Inc	FPO	2014-12-03
Z-1216-2015	Class II	RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy...	Arjohuntleigh AB	IKZ	2014-12-03
Z-0971-2015	Class II	SOMATOM Force; the intended use of computed tomography is to produce cross-sectional...	Siemens Medical Solutions USA, Inc.	JAK	2014-12-03
Z-0857-2015	Class II	RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal...	International Remote Imaging Systems	JQC	2014-12-03
Z-0802-2015	Class I	GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF...	Leonhard Lang GmbH	MKJ	2014-12-03
Z-0929-2015	Class II	IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0928-2015	Class II	Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0927-2015	Class II	IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient...	Hill-Rom Inc.	JEA	2014-12-03
Z-0926-2015	Class II	Cable remote control JUX Material, no.1307315, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0925-2015	Class II	(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0924-2015	Class II	(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0923-2015	Class II	IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0922-2015	Class II	IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0921-2015	Class II	IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0920-2015	Class II	Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0919-2015	Class II	Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0918-2015	Class II	Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.)...	Hill-Rom Inc.	JEA	2014-12-03
Z-0826-2015	Class II	WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are...	Teleflex Medical	FZP	2014-12-03
Z-0980-2015	Class II	Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR...	Siemens Medical Solutions USA, Inc.	IYE	2014-12-02
Z-0823-2015	Class II	Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification...	Zimmer GmbH	JDI	2014-12-02
Z-0822-2015	Class II	Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name...	Zimmer GmbH	JDI	2014-12-02
Z-0821-2015	Class II	VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021...	Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work	IYE	2014-12-02
Z-0851-2015	Class II	NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5...	Zimmer Trabecular Metal Technology, Inc.	HXB	2014-12-02
Z-0970-2015	Class II	EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is...	Globus Medical, Inc.	JWH	2014-12-01
Z-0346-2018	Class I	Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification...	Jaeger Medical GmbH	BTT	2014-11-29
Z-0345-2018	Class I	Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber...	Jaeger Medical GmbH	BTT	2014-11-29
Z-0344-2018	Class I	Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife...	Jaeger Medical GmbH	BTT	2014-11-29
Z-0343-2018	Class I	Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife...	Jaeger Medical GmbH	BTT	2014-11-29
Z-1926-2017	Class I	Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010	Magellan Diagnostics, Inc.	DOF	2014-11-29
Z-1925-2017	Class I	Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010	Magellan Diagnostics, Inc.	DOF	2014-11-29
Z-0609-2019	Class II	Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit...	Mazor Robotics Ltd	HAW	2014-11-26
Z-1081-2015	Class III	VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn...	Lacrimedics, Inc.	LZU	2014-11-26
Z-0930-2015	Class II	Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED...	STERIS Corporation	FST	2014-11-26
Z-1065-2015	Class II	SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11...	SCC Soft Computer	JQP	2014-11-26
Z-0852-2015	Class II	GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350...	Getinge Disinfection AB	MEC	2014-11-26
Z-1284-2015	Class II	TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF)...	Abbott Medical	OAE	2014-11-25