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 571 of 1191

FDA device recalls, page 571 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0116-2018	Class II	Rosa Brain 3.0.0	Zimmer GmbH	HAW	2016-07-29
Z-0691-2017	Class II	Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures	B Braun Medical Inc	LRS	2016-07-29
Z-2896-2016	Class II	Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or...	Zyno Medical LLC.	FPA	2016-07-29
Z-2895-2016	Class II	Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or...	Zyno Medical LLC.	FPA	2016-07-29
Z-2894-2016	Class II	Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or...	Zyno Medical LLC.	FPA	2016-07-29
Z-2893-2016	Class II	Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or...	Zyno Medical LLC.	FPA	2016-07-29
Z-0014-2018	Class II	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF...	Direct Healthcare Group Sverige AB	FSA	2016-07-28
Z-2790-2016	Class II	Hospira MedNet Medication Management Suite software, version 6.1, List Numbers...	Abbott Medical	FRN	2016-07-28
Z-2580-2016	Class III	VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191...	Ortho-Clinical Diagnostics, Inc.	JLW	2016-07-28
Z-2834-2016	Class II	LAUREATE World Phaco System	Alcon Laboratories	HQC	2016-07-28
Z-2708-2016	Class II	Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ...	Alcon Laboratories	HQL	2016-07-28
Z-2844-2016	Class II	3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking...	Orthopediatrics Corp	HWC	2016-07-27
Z-2843-2016	Class II	3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking...	Orthopediatrics Corp	HWC	2016-07-27
Z-2604-2016	Class II	CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs...	Innokas Medical Oy	MWI	2016-07-27
Z-2878-2016	Class II	Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software...	Siemens Medical Solutions USA, Inc.	IYE	2016-07-26
Z-2877-2016	Class II	PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is...	Siemens Medical Solutions USA, Inc.	IYE	2016-07-26
Z-2876-2016	Class II	ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM...	Siemens Medical Solutions USA, Inc.	IYE	2016-07-26
Z-2788-2016	Class II	AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages...	Howmedica Osteonics Corp	MAX	2016-07-26
Z-2787-2016	Class II	AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages...	Howmedica Osteonics Corp	MAX	2016-07-26
Z-2786-2016	Class II	AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages...	Howmedica Osteonics Corp	MAX	2016-07-26
Z-2606-2016	Class II	Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate...	Encore Medical, LP	LOD	2016-07-26
Z-2328-2016	Class II	IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health...	Philips North America LLC	MHX	2016-07-26
Z-2884-2016	Class II	DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate...	Microgenics Corporation	DKJ	2016-07-25
Z-2706-2016	Class II	Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing...	Terumo Cardiovascular Systems Corporation	OEZ	2016-07-25
Z-2666-2016	Class II	Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument...	Tecan U.S.	LXG	2016-07-25
Z-2665-2016	Class II	Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional...	Tecan U.S.	JJQ	2016-07-25
Z-2664-2016	Class II	Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based...	Tecan U.S.	JJQ	2016-07-25
Z-2663-2016	Class II	Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with...	Tecan U.S.	JJQ	2016-07-25
Z-2662-2016	Class II	Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the...	Tecan U.S.	JJQ	2016-07-25
Z-2661-2016	Class II	SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the...	Tecan U.S.	JJQ	2016-07-25
Z-2660-2016	Class II	Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for...	Tecan U.S.	JJQ	2016-07-25
Z-2629-2016	Class II	OEC 9800, fluoroscopic x-ray system	GE Healthcare	OWB	2016-07-22
Z-2628-2016	Class II	OEC UroView 2800, fluoroscopic x-ray system	GE Healthcare	OWB	2016-07-22
Z-0760-2017	Class II	INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can...	Inovo Inc.	CAW	2016-07-21
Z-2848-2016	Class II	RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the...	Smith & Nephew, Inc.	OMP	2016-07-21
Z-2600-2016	Class II	Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product...	Integra LifeSciences Corporation	HWC	2016-07-21
Z-2835-2016	Class II	FPS 35mm x 3.5 mm non-locking screw	Ortho Solutions Inc	HWC	2016-07-21
Z-2707-2016	Class II	SMR allen wrench 5 mm, product code 9013.50.210	Limacorporate S.p.A.	LXH	2016-07-21
Z-0167-2018	Class II	ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and...	Zimmer GmbH	HAW	2016-07-20
Z-0937-2017	Class III	Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC...	Sterling Diagnostics, Inc.	LFQ	2016-07-20
Z-0936-2017	Class III	Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the...	Sterling Diagnostics, Inc.	CDL	2016-07-20
Z-0935-2017	Class III	Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the...	Sterling Diagnostics, Inc.	CKA	2016-07-20
Z-0934-2017	Class III	Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the...	Sterling Diagnostics, Inc.	CIQ	2016-07-20
Z-0933-2017	Class III	Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in...	Sterling Diagnostics, Inc.	JIY	2016-07-20
Z-0932-2017	Class III	Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the...	Sterling Diagnostics, Inc.	CGA	2016-07-20
Z-0931-2017	Class III	Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the...	Sterling Diagnostics, Inc.	CGX	2016-07-20
Z-0930-2017	Class III	Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in...	Sterling Diagnostics, Inc.	LBR	2016-07-20
Z-0929-2017	Class III	Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative...	Sterling Diagnostics, Inc.	CHH	2016-07-20
Z-2917-2016	Class II	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic...	Medtronic, Inc.	OEA	2016-07-20
Z-2403-2016	Class I	OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the...	OraSure Technologies, Inc.		2016-07-20