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 621 of 1191

FDA device recalls, page 621 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0457-2016	Class III	DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output...	BC Group International Inc	DRL	2015-10-28
Z-0319-2016	Class II	Syngo Imaging VB36D_HF02. Radiological image processing system.	Siemens Medical Solutions USA, Inc.	LLZ	2015-10-28
Z-0396-2016	Class II	DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A...	Implant Direct Sybron Manufacturing LLC	NHA	2015-10-28
Z-0268-2016	Class II	Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized...	Medtronic Perfusion Systems	DWF	2015-10-28
Z-0356-2016	Class II	ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single...	Baylis Medical Co., Inc.	DQX	2015-10-28
Z-0361-2016	Class II	Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10...	Quest Medical, Inc	DTR	2015-10-28
Z-0355-2016	Class II	U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in...	Procedure Products, Inc.	DRE	2015-10-27
Z-0358-2016	Class II	IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended...	Carl Zeiss Meditec Inc	HJO	2015-10-27
Z-0357-2016	Class II	IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular...	Carl Zeiss Meditec Inc	HJO	2015-10-27
Z-0322-2016	Class III	Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and...	Lab Vision Corp.	NTR	2015-10-27
Z-0623-2016	Class II	Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft...	ArthroCare Corporation	GEI	2015-10-26
Z-0555-2016	Class II	Merge Cardio with software version 10.1 LA.	Merge Healthcare Incorporated	LLZ	2015-10-26
Z-0554-2016	Class II	Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite...	Merge Healthcare Incorporated	DQK	2015-10-26
Z-0368-2016	Class II	PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable...	Merz North America, Inc.	KHJ	2015-10-26
Z-0367-2016	Class II	PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material...	Merz North America, Inc.	MIX	2015-10-26
Z-0366-2016	Class II	Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal...	Merz North America, Inc.	LMH	2015-10-26
Z-0279-2016	Class II	MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot...	Astora	PAH	2015-10-26
Z-0401-2016	Class II	GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head...	GE Healthcare	JAK	2015-10-23
Z-0243-2016	Class II	Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152...	Medtronic, Inc.	DQY	2015-10-23
Z-0209-2016	Class II	iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66...	Otto Bock Healthcare LP	ISH	2015-10-23
Z-0296-2016	Class II	Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2015-10-23
Z-0295-2016	Class II	Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2015-10-23
Z-0294-2016	Class II	Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2015-10-23
Z-0639-2016	Class II	Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece...	Mercury Medical Enterprises, LLC	BTL	2015-10-22
Z-0264-2016	Class II	CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans	Innokas Medical Oy	MWI	2015-10-22
Z-0390-2016	Class II	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0389-2016	Class II	LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0388-2016	Class II	LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0387-2016	Class II	LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0386-2016	Class II	LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0385-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0384-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0383-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0382-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0381-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0380-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0379-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0378-2016	Class II	LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34...	LeMaitre Vascular Inc.	DXE	2015-10-21
Z-0321-2016	Class II	Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by...	Medtronic Powered Surgical Solutions	HBB	2015-10-21
Z-0290-2016	Class II	CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used...	CIVCO Medical Instruments Co., Inc.	ITX	2015-10-21
Z-0289-2016	Class II	CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with...	CIVCO Medical Instruments Co., Inc.	ITX	2015-10-21
Z-0288-2016	Class II	CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16...	CIVCO Medical Instruments Co., Inc.	ITX	2015-10-21
Z-0287-2016	Class II	CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14...	CIVCO Medical Instruments Co., Inc.	ITX	2015-10-21
Z-0244-2016	Class II	Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for...	Cook Incorporated	KRA	2015-10-21
Z-0286-2016	Class II	CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO...	CIVCO Medical Instruments Co., Inc.	ITX	2015-10-21
Z-0373-2016	Class II	Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM...	Smith & Nephew, Inc.	HRS	2015-10-20
Z-0372-2016	Class II	Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM...	Smith & Nephew, Inc.	HRS	2015-10-20
Z-0324-2016	Class II	SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free...	Orthopediatrics Canada ULC	HWC	2015-10-20
Z-0317-2016	Class II	THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests...	Ameditech, Inc.	JXM	2015-10-20
Z-0316-2016	Class II	The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No...	Ameditech, Inc.	JXM	2015-10-20