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 723 of 1191

FDA device recalls, page 723 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0891-2014	Class II	Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc...	Synergetics Inc	HQB	2013-12-09
Z-0890-2014	Class II	25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0889-2014	Class II	23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0888-2014	Class II	"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft...	Synergetics Inc	HQB	2013-12-09
Z-0887-2014	Class II	27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0886-2014	Class II	Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS...	Synergetics Inc	HQB	2013-12-09
Z-0885-2014	Class II	25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12...	Synergetics Inc	HQB	2013-12-09
Z-0884-2014	Class II	23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft...	Synergetics Inc	HQB	2013-12-09
Z-0883-2014	Class II	Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12...	Synergetics Inc	HQB	2013-12-09
Z-0882-2014	Class II	23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile...	Synergetics Inc	HQB	2013-12-09
Z-0881-2014	Class II	27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0880-2014	Class II	25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12...	Synergetics Inc	HQB	2013-12-09
Z-0879-2014	Class II	25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile /...	Synergetics Inc	HQB	2013-12-09
Z-0878-2014	Class II	29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P...	Synergetics Inc	HQB	2013-12-09
Z-0877-2014	Class II	25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12...	Synergetics Inc	HQB	2013-12-09
Z-0876-2014	Class II	23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0875-2014	Class II	Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0874-2014	Class II	Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO...	Synergetics Inc	HQB	2013-12-09
Z-0873-2014	Class II	23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P...	Synergetics Inc	HQB	2013-12-09
Z-1077-2014	Class II	PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during...	Depuy Orthopaedics Inc.	JWH	2013-12-09
Z-0872-2014	Class II	Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units...	Synergetics Inc	HQB	2013-12-09
Z-0652-2014	Class II	Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10...	ArthroCare Corporation	LXH	2013-12-09
Z-0623-2014	Class II	Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and...	Aesculap Inc	GET	2013-12-09
Z-1471-2014	Class I	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers...	HeartWare, Inc.	DSQ	2013-12-06
Z-0975-2014	Class II	Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102...	Howmedica Osteonics Corp	KKY	2013-12-06
Z-0939-2014	Class II	*REF 606-01-05*OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	2013-12-06
Z-0614-2014	Class II	Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular...	Merit Medical Systems, Inc.	KRA	2013-12-06
Z-0775-2014	Class II	Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured...	Lab Vision Corp.	MVU	2013-12-06
Z-0630-2014	Class II	Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x...	Stryker Corp.	KCY	2013-12-06
Z-0815-2014	Class II	Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr...	Bard Access Systems, Inc.	FOZ	2013-12-06
Z-0814-2014	Class II	MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code...	Bard Access Systems, Inc.	FOZ	2013-12-06
Z-0994-2014	Class II	Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended...	Integra LifeSciences Corporation		2013-12-05
Z-0979-2014	Class II	GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System...	Philips North America LLC	KPS	2013-12-05
Z-0833-2014	Class II	Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container...	Symmetry Surgical GmbH	KCT	2013-12-05
Z-0787-2014	Class II	PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D...	Siemens Medical Solutions USA, Inc.	JAI	2013-12-05
Z-0848-2014	Class II	Compressor Mini To provide a supply of dry, filtered compressed air for a medical...	Maquet Cardiovascular Us Sales, LLC	BTI	2013-12-05
Z-0808-2014	Class II	GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM...	GE Healthcare	MHX	2013-12-05
Z-0807-2014	Class II	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare...	GE Healthcare	MHX	2013-12-05
Z-0806-2014	Class II	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the...	GE Healthcare	MHX	2013-12-05
Z-0818-2014	Class II	Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the...	Siemens Healthcare Diagnostics Inc.	MKW	2013-12-05
Z-1202-2014	Class II	Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic...	Siemens Medical Solutions USA, Inc.	OWB	2013-12-05
Z-0584-2014	Class II	Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta...	Philips North America LLC	MQB	2013-12-05
Z-0534-2014	Class I	Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode...	CareFusion 303, Inc	FRN	2013-12-05
Z-1492-2014	Class II	Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110...	Ion Beam Applications S.A.	LHN	2013-12-04
Z-0983-2014	Class II	Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a...	Invivo Corporation	MWI	2013-12-04
Z-0857-2014	Class II	CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended...	LivaNova Deutschland GmbH	DWA	2013-12-04
Z-0856-2014	Class II	S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to...	LivaNova Deutschland GmbH	DTQ	2013-12-04
Z-0801-2014	Class II	Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big...	Philips North America LLC	JAK	2013-12-04
Z-0932-2014	Class II	Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438...	Philips North America LLC	KPS	2013-12-04
Z-0785-2014	Class II	ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by...	Philips North America LLC	IZJ	2013-12-04