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 730 of 1191

FDA device recalls, page 730 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1088-2014	Class II	VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics...	Ortho-Clinical Diagnostics, Inc.	JIX	2013-10-17
Z-1087-2014	Class II	VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513...	Ortho-Clinical Diagnostics, Inc.	JGS	2013-10-17
Z-0351-2014	Class II	Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor...	GE Healthcare	MHX	2013-10-17
Z-0188-2014	Class II	Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a...	GE Healthcare	MHX	2013-10-17
Z-0352-2014	Class I	CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the...	GE Healthcare	BSZ	2013-10-17
Z-0272-2014	Class II	Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5...	GlaxoSmithKline, LLC.	LFD	2013-10-17
Z-0368-2014	Class II	EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic...	Philips North America LLC	IYN	2013-10-17
Z-1079-2014	Class II	Trabecular Metal" Reverse Shoulder System	Zimmer GmbH	KWT	2013-10-17
Z-2168-2014	Class III	Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and...	Luminex Corporation	OZN	2013-10-16
Z-1062-2014	Class II	Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary...	Bausch & Lomb Incorporated	HQL	2013-10-16
Z-1292-2015	Class II	The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro...	Baxter Healthcare Corporation	FKX	2013-10-16
Z-0427-2014	Class II	Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency...	Cutera Inc	OPT	2013-10-16
Z-0513-2014	Class II	Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number...	Microgenics Corporation	LFW	2013-10-16
Z-0556-2014	Class II	McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).	Mckesson Information Solutions, LLC	LLZ	2013-10-15
Z-0816-2014	Class II	ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable...	Radiometer America, Inc	JGS	2013-10-15
Z-0366-2014	Class II	Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway...	Teleflex Medical	CCW	2013-10-15
Z-0393-2014	Class II	Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL...	Synthes GmbH	LXH	2013-10-15
Z-1045-2015	Class II	Philips Multi Diagnost Eleva with FlatDetector	Philips North America LLC	IZI	2013-10-14
Z-1044-2015	Class II	Philips Multi Diagnost Eleva II	Philips North America LLC	IZI	2013-10-14
Z-2152-2014	Class II	VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of...	bioMerieux, Inc.	MTF	2013-10-14
Z-0404-2014	Class II	Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer...	Synthes (USA) Products LLC	JDS	2013-10-14
Z-0269-2014	Class II	Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software...	Philips North America LLC	LLZ	2013-10-14
Z-0148-2014	Class II	Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2013-10-14
Z-0356-2014	Class II	ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle...	Venus Concept Inc.	ONA	2013-10-13
Z-0355-2014	Class II	Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly...	Venus Concept Inc.	ONA	2013-10-13
Z-0354-2014	Class II	ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube...	Venus Concept Inc.	ONA	2013-10-13
Z-0353-2014	Class II	Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using...	Venus Concept Inc.	ONA	2013-10-13
Z-1044-2014	Class II	3.5 X 10 Cort Screw Selft 3.5 X 12 Cort Screw Selft 3.5 X 14 Cort Screw Selft 3.5 X 16...	Zimmer GmbH	HWC	2013-10-11
Z-1043-2014	Class II	3.5 Comp Plt, 4 Hole 3.5 Comp Plt, 5 Hole 3.5 Comp Plt, 6 Hole 3.5 Comp...	Zimmer GmbH	HRS	2013-10-11
Z-1042-2014	Class II	1.5 X 6 Cort Screw Hex/se 2.0 X 6 Cort Screw Hex/se 2.0 X 10 Cort Screw Cruci 2.0 X 12...	Zimmer GmbH	HWC	2013-10-11
Z-1041-2014	Class II	2.7 X 6 Cort Screw/selfta 2.7 X 7 Cort Screw/selfta 2.7 X 8 Cort Screw/selfta 2.7 X 9...	Zimmer GmbH	HWC	2013-10-11
Z-1040-2014	Class II	Peri Scr. 3.5Mm X 10Mm Peri Scr. 3.5Mm X 12Mm Peri Scr. 3.5Mm X 14Mm Peri Scr...	Zimmer GmbH	HWC	2013-10-11
Z-1039-2014	Class II	Compression Screw (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 in)	Zimmer GmbH	KTT	2013-10-11
Z-1038-2014	Class II	HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S	Zimmer GmbH	HWC	2013-10-11
Z-1037-2014	Class II	FEM HD ION (various sizes)	Zimmer GmbH	JWH	2013-10-11
Z-1036-2014	Class II	CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)	Zimmer GmbH	JDI	2013-10-11
Z-1035-2014	Class II	MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID	Zimmer GmbH	JDG	2013-10-11
Z-1034-2014	Class II	6 Degree Cocr Fem Head 36	Zimmer GmbH	LPH	2013-10-11
Z-1033-2014	Class II	6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE	Zimmer GmbH	JDI	2013-10-11
Z-1032-2014	Class II	CPT 12/14 COCR (various sizes)	Zimmer GmbH	JDI	2013-10-11
Z-1031-2014	Class II	12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)	Zimmer GmbH	LPH	2013-10-11
Z-1030-2014	Class II	Zimtron 6 Deg 22 Heads	Zimmer GmbH	JDI	2013-10-11
Z-1029-2014	Class II	12/14 Unipolar Femoral He Versys Cem Ld/fx Sz 11X12 Versys Cem Ld/fx Sz 12X12 Versys Cem...	Zimmer GmbH	JDI	2013-10-11
Z-1028-2014	Class II	Versys Heritage Fem Stem	Zimmer GmbH	MRA	2013-10-11
Z-1027-2014	Class II	Pressfit Fem St Fx 16 X 1	Zimmer GmbH	LWJ	2013-10-11
Z-1026-2014	Class II	Hgp II Acetabular Cup Mod	Zimmer GmbH	LPH	2013-10-11
Z-1025-2014	Class II	Hgp II Acetabular Cup Bon	Zimmer GmbH	JDI	2013-10-11
Z-1024-2014	Class II	Trilogy Acet Shell 36Mm O Trilogy Acet Shell 38Mm O Trilogy Acet Shell 40Mm O Trilogy...	Zimmer GmbH	LPH	2013-10-11
Z-1023-2014	Class II	Modular Cup Neutral Liner Modular Cup 10 Degree Lin Modular Cup 20 Degree Lin Modular Cup...	Zimmer GmbH	LPH	2013-10-11
Z-1022-2014	Class II	Nexgen Mis Tibia Plate Pr Nexgen Taper Plug Nexgen Precoat Peg Tib Pl Nexgen...	Zimmer GmbH	JWH	2013-10-11