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 596 of 1191

FDA device recalls, page 596 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1290-2016	Class II	Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1289-2016	Class II	Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1288-2016	Class II	Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with...	Ossur Iceland ehf.	IQK	2016-02-24
Z-1287-2016	Class II	NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients...	Ossur Iceland ehf.	IQK	2016-02-24
Z-1286-2016	Class II	Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for...	Ossur Iceland ehf.	ITQ	2016-02-24
Z-1285-2016	Class II	Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used...	Ossur Iceland ehf.	IQI	2016-02-24
Z-1251-2016	Class II	IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No...	Amd-Ritmed, Inc.	MHW	2016-02-24
Z-1374-2016	Class II	Custom Tubing Packs Custom tubing pack for oxygenators	Maquet Cardiovascular Us Sales, LLC	KFM	2016-02-23
Z-1327-2016	Class II	Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833...	Synthes (USA) Products LLC	DZL	2016-02-23
Z-1326-2016	Class II	Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833...	Synthes (USA) Products LLC	DZL	2016-02-23
Z-1391-2016	Class II	X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation...	X-NAV Technologies, LLC	PLV	2016-02-23
Z-1583-2016	Class II	RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for...	Mako Surgical Corp.	OLO	2016-02-23
Z-1249-2016	Class II	Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG...	Medtronic, Inc.	DSI	2016-02-23
Z-1187-2016	Class II	Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna...	Covidien Medical Products (Shanghai) Manufacturing LLC	NEY	2016-02-23
Z-1339-2016	Class I	Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black...	Dexcom, Inc.	MDS	2016-02-23
Z-1338-2016	Class I	Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver...	Dexcom, Inc.	MDS	2016-02-23
Z-1337-2016	Class I	Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL)...	Dexcom, Inc.	MDS	2016-02-23
Z-1336-2016	Class I	Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver...	Dexcom, Inc.	MDS	2016-02-23
Z-1335-2016	Class I	Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL)...	Dexcom, Inc.	MDS	2016-02-23
Z-1334-2016	Class I	Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black...	Dexcom, Inc.	MDS	2016-02-23
Z-1373-2016	Class II	Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator	Maquet Cardiovascular Us Sales, LLC	KFM	2016-02-23
Z-1372-2016	Class II	HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator	Maquet Cardiovascular Us Sales, LLC	DTQ	2016-02-23
Z-1371-2016	Class II	QUADROX-i oxygenators Custom tubing packs for the oxygenator	Maquet Cardiovascular Us Sales, LLC	DTZ	2016-02-23
Z-1233-2016	Class II	cobas p 512 pre-analytical system Pre-analytical sample handling that includes...	Roche Diagnostics GmbH	JQP	2016-02-23
Z-1252-2016	Class II	Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#...	Innovative Ophthalmic Products, Inc	KYF	2016-02-22
Z-1835-2016	Class II	Video Duodenoscope	PENTAX of America, Inc.	FDT	2016-02-22
Z-1234-2016	Class II	BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a...	Medtronic Navigation, Inc	HAW	2016-02-22
Z-1911-2016	Class II	Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit...	Integrated Science Systems Inc	LHJ	2016-02-19
Z-1311-2016	Class II	Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-19
Z-1278-2016	Class II	Cios Alpha, mobile X-ray system	Siemens Medical Solutions USA, Inc.	OWB	2016-02-19
Z-1310-2016	Class II	AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and...	Siemens Medical Solutions USA, Inc.	JAA	2016-02-19
Z-1066-2017	Class II	Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph...	Acteon, Inc.	KXJ	2016-02-19
Z-1065-2017	Class II	Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph...	Acteon, Inc.	KXJ	2016-02-19
Z-1064-2017	Class II	Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131...	Acteon, Inc.	KXJ	2016-02-19
Z-1063-2017	Class II	Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and...	Acteon, Inc.	KXJ	2016-02-19
Z-1501-2016	Class II	CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively...	Medtronic, Inc.	OUG	2016-02-19
Z-1554-2016	Class II	Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete...	Horiba Instruments Incorporated	JJE	2016-02-19
Z-1553-2016	Class II	ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete...	Horiba Instruments Incorporated	JJE	2016-02-19
Z-3099-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3098-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3097-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3096-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3095-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3094-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3093-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3092-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	IZI	2016-02-18
Z-3091-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-18
Z-3090-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-18
Z-3089-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-18
Z-3088-2017	Class II	Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and...	Siemens Medical Solutions USA, Inc.	OWB	2016-02-18