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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 767 of 1190

FDA device recalls, page 767 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0861-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0860-2013	Class II	NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0859-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0858-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0857-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0856-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0855-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0854-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0853-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0852-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0851-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0850-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0849-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0848-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0847-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0846-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0845-2013	Class II	NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0844-2013	Class II	NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0843-2013	Class II	NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0842-2013	Class II	NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0952-2013	Class II	Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire...	Extremity Medical, LLC	HXI	2013-01-10
Z-1168-2013	Class II	Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW &...	GE Healthcare	KPS	2013-01-09
Z-0750-2013	Class II	Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem...	Envoy Medical Corporation	OAF	2013-01-09
Z-1051-2013	Class I	Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part...	GE Healthcare	FMZ	2013-01-08
Z-0794-2013	Class II	SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in...	Allergen Medical	FTL	2013-01-08
Z-0920-2013	Class II	Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended...	Integra LifeSciences Corporation	LBK	2013-01-07
Z-0671-2013	Class II	Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm)...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0670-2013	Class II	Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm)...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0669-2013	Class II	Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0668-2013	Class II	Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0667-2013	Class II	Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0666-2013	Class II	Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring...	Terumo Cardiovascular Systems Corporation	DWF	2013-01-07
Z-0005-2014	Class II	The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville...	PhotoMedex, Inc.	GEX	2013-01-04
Z-0831-2013	Class I	LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS...	Depuy Orthopaedics Inc.	MBH	2013-01-04
Z-0830-2013	Class I	LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS...	Depuy Orthopaedics Inc.	MBH	2013-01-04
Z-0829-2013	Class I	LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS...	Depuy Orthopaedics Inc.	MBH	2013-01-04
Z-0828-2013	Class I	LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS...	Depuy Orthopaedics Inc.	MBH	2013-01-04
Z-0993-2013	Class I	Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for...	Animas Corp.	LZG	2013-01-03
Z-0753-2013	Class II	TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a...	Zimmer GmbH	HWC	2013-01-03
Z-0795-2013	Class I	The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under...	Lumenis Ltd	GCJ	2013-01-02
Z-0792-2013	Class III	Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A...	Ortho-Clinical Diagnostics, Inc.	LKA	2012-12-31
Z-1950-2013	Class II	CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS...	Veridex, LLC	NQI	2012-12-28
Z-1949-2013	Class II	CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The...	Veridex, LLC	NQI	2012-12-28
Z-0958-2013	Class II	Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the...	Siemens Healthcare Diagnostics Inc.	CGX	2012-12-28
Z-1323-2013	Class II	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)	HeartWare, Inc.	DSQ	2012-12-27
Z-0893-2013	Class II	Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive...	Howmedica Osteonics Corp	LXH	2012-12-27
Z-0737-2013	Class II	UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation...	ConMed Corporation	GEI	2012-12-27
Z-0736-2013	Class II	UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single...	ConMed Corporation	GEI	2012-12-27
Z-0735-2013	Class II	UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation...	ConMed Corporation	GEI	2012-12-27
Z-0734-2013	Class II	UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation...	ConMed Corporation	GEI	2012-12-27