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 744 of 1191

FDA device recalls, page 744 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1783-2013	Class II	Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH...	Pemco Inc	GAD	2013-07-10
Z-1934-2013	Class II	Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of...	Medtronic Xomed, Inc.	MMO	2013-07-09
Z-1945-2014	Class II	Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.	Baxter Healthcare Corporation	KDI	2013-07-08
Z-2099-2013	Class II	Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III...	Howmedica Osteonics Corp	HWC	2013-07-08
Z-1985-2013	Class II	Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung...	LivaNova USA, Inc.	DWF	2013-07-08
Z-2112-2013	Class II	PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.	Becton Dickinson & Co	MKQ	2013-07-08
Z-2111-2013	Class II	PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.	Becton Dickinson & Co	MKQ	2013-07-08
Z-2110-2013	Class II	PrepStain AG. For use in the screening and detection of cervical cancer.	Becton Dickinson & Co	MKQ	2013-07-08
Z-1876-2013	Class II	Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of...	Medtronic, Inc.	DYB	2013-07-08
Z-1996-2013	Class II	GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM...	Smith & Nephew, Inc.	JWH	2013-07-08
Z-1780-2013	Class II	Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 &...	Philips North America LLC	MHX	2013-07-08
Z-1075-2014	Class II	pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic...	Radiometer America, Inc	CHL	2013-07-05
Z-2210-2013	Class II	Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235...	Philips North America LLC	JAK	2013-07-05
Z-1729-2013	Class II	Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless...	KooJoo Trading Company	FMK	2013-07-03
Z-1986-2013	Class II	Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A...	Medtronic, Inc.	FRN	2013-07-03
Z-2276-2013	Class II	Monaco RTP System Radiation treatment planning	Elekta Limited	MUJ	2013-07-02
Z-2130-2013	Class II	Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM)...	Howmedica Osteonics Corp	GDJ	2013-07-02
Z-0948-2014	Class II	Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699...	Microtek Medical LLC	KKX	2013-07-02
Z-0947-2014	Class II	MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x...	Microtek Medical LLC	KKX	2013-07-02
Z-0946-2014	Class II	MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98"...	Microtek Medical LLC	KKX	2013-07-02
Z-0945-2014	Class II	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x...	Microtek Medical LLC	KKX	2013-07-02
Z-0944-2014	Class II	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm...	Microtek Medical LLC	KKX	2013-07-02
Z-0943-2014	Class II	MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244...	Microtek Medical LLC	KKX	2013-07-02
Z-1874-2013	Class I	MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the...	Iradimed Corporation	FRN	2013-07-01
Z-1924-2013	Class II	Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL...	Siemens Healthcare Diagnostics Inc.	MLM	2013-07-01
Z-1742-2013	Class II	RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System...	Stryker Corp.	ERL	2013-07-01
Z-1741-2013	Class II	CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal...	Stryker Corp.	ERL	2013-07-01
Z-1740-2013	Class II	Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System...	Stryker Corp.	ERL	2013-07-01
Z-2086-2013	Class II	Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation...	Alphatec Spine, Inc.	NKB	2013-06-28
Z-1970-2013	Class III	ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN...	Siemens Healthcare Diagnostics Inc.	JIS	2013-06-28
Z-1810-2013	Class II	Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with...	Medtronic Neurosurgery	KYZ	2013-06-28
Z-1954-2013	Class II	REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere...	Zimmer GmbH	LXH	2013-06-28
Z-1953-2013	Class II	REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere...	Zimmer GmbH	LXH	2013-06-28
Z-0144-2014	Class II	MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge...	Insight Instruments, Inc.	HNJ	2013-06-27
Z-1213-2014	Class II	Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975...	Evoqua Water Technologies LLC	FIP	2013-06-26
Z-2114-2013	Class II	ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120...	Siemens Healthcare Diagnostics Inc.	GKL	2013-06-26
Z-1782-2013	Class II	ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have...	Siemens Medical Solutions USA, Inc.	IZI	2013-06-26
Z-2047-2013	Class II	PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers...	Siemens Healthcare Diagnostics Inc.	MFT	2013-06-26
Z-1991-2013	Class III	ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal...	ConvaTec Limited	KNT	2013-06-25
Z-1990-2013	Class III	ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to...	ConvaTec Limited	KNT	2013-06-25
Z-1960-2014	Class II	ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370...	Siemens Healthcare Diagnostics Inc.	LPS	2013-06-25
Z-2136-2013	Class II	SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis...	Globus Medical, Inc.	JWH	2013-06-24
Z-1880-2013	Class II	Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The...	Stryker Corp.	LFL	2013-06-24
Z-1879-2013	Class II	Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The...	Stryker Corp.	LFL	2013-06-24
Z-1808-2013	Class II	Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number...	Stryker Corp.	NJE	2013-06-24
Z-1878-2013	Class II	Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The...	Stryker Corp.	LFL	2013-06-24
Z-0391-2014	Class II	Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm...	Synthes GmbH	HXP	2013-06-22
Z-1931-2013	Class II	MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier...	Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work	IYE	2013-06-21
Z-2156-2013	Class II	LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21
Z-2155-2013	Class II	LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a...	Genzyme Corporation, A Sanofi Company	OBC	2013-06-21