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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 296 of 1190

FDA device recalls, page 296 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2510-2021	Class II	Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F...	Aesculap Inc	HRY	2021-03-19
Z-2509-2021	Class II	Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F...	Aesculap Inc	HRY	2021-03-19
Z-2004-2021	Class II	Revolution CT	GE Healthcare	JAK	2021-03-19
Z-1533-2021	Class II	Centricity Universal Viewer - Product Usage: intended to assist in the viewing...	GE Healthcare	LLZ	2021-03-19
Z-1486-2021	Class II	Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization...	Cardiac Assist, Inc	DRE	2021-03-19
Z-1493-2021	Class II	Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents...	Cytocell Limited	MVU	2021-03-19
Z-1497-2021	Class II	Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor...	Siemens Medical Solutions USA, Inc.	OWB	2021-03-19
Z-1487-2021	Class II	Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled...	Baxter Healthcare Corporation	FRN	2021-03-19
Z-2049-2023	Class II	LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left	Waldemar Link GmbH & Co. KG	KRO	2021-03-18
Z-2048-2023	Class II	LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right	Waldemar Link GmbH & Co. KG	KRO	2021-03-18
Z-2047-2023	Class II	LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left	Waldemar Link GmbH & Co. KG	KRO	2021-03-18
Z-2046-2023	Class II	LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right	Waldemar Link GmbH & Co. KG	KRO	2021-03-18
Z-0504-2022	Class II	Gentueri Viral Transport Medium (VTM), Sterile, IVD	Gentueri Inc	JSM	2021-03-18
Z-1536-2021	Class II	AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use...	Fresenius Medical Care Renal Therapies Group, LLC	FIP	2021-03-18
Z-1494-2021	Class II	Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth...	Coltene /Whaledent AG	EBL	2021-03-18
Z-1488-2021	Class II	VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic...	Luminex Corporation	PCH	2021-03-18
Z-2517-2021	Class II	Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1...	Sight Diagnostics, Ltd.	GKZ	2021-03-17
Z-1503-2021	Class II	Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for...	Trinity Biotech USA	PCL	2021-03-17
Z-1440-2021	Class II	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large...	Medtronic Sofamor Danek USA Inc	MAX	2021-03-17
Z-1439-2021	Class II	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small...	Medtronic Sofamor Danek USA Inc	MAX	2021-03-17
Z-1508-2021	Class II	Change Healthcare Enterprise Viewer	Change Healthcare Canada Company	LLZ	2021-03-17
Z-1354-2021	Class II	CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm...	Integra LifeSciences Corporation	HCA	2021-03-17
Z-1378-2021	Class II	BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic...	Becton Dickinson & Co	JTY	2021-03-17
Z-1377-2021	Class II	BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic...	Becton Dickinson & Co	JTY	2021-03-17
Z-1942-2021	Class II	ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862	Medtronic, Inc.	NBW	2021-03-16
Z-1941-2021	Class II	OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326	Medtronic, Inc.	NVP	2021-03-16
Z-1940-2021	Class II	ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628	Medtronic, Inc.	FMK	2021-03-16
Z-1939-2021	Class II	ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610	Medtronic, Inc.	FMK	2021-03-16
Z-1938-2021	Class II	ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443	Medtronic, Inc.	NBW	2021-03-16
Z-1937-2021	Class II	ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788	Medtronic, Inc.	FMK	2021-03-16
Z-1936-2021	Class II	ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174	Medtronic, Inc.	NBW	2021-03-16
Z-1935-2021	Class II	VAPORIZER VICKS 1.5GAL Item Number: 2354942	Medtronic, Inc.	KFZ	2021-03-16
Z-1934-2021	Class II	DEXCOM G6 SENSOR 3 PACK Item Number: 5447552	Medtronic, Inc.	QBJ	2021-03-16
Z-1933-2021	Class II	BD UF PEN 32GX4MM 100 NANO Item Number: 4292272	Medtronic, Inc.	FMI	2021-03-16
Z-1932-2021	Class II	AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033	Medtronic, Inc.	NVP	2021-03-16
Z-1931-2021	Class II	FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877	Medtronic, Inc.	QLG	2021-03-16
Z-1930-2021	Class II	FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084	Medtronic, Inc.	PZE	2021-03-16
Z-1929-2021	Class II	FREESTYLE LANCETS 28G 100CT Item Number:2975670	Medtronic, Inc.	FMK	2021-03-16
Z-1590-2021	Class II	REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the...	Abbott Medical	N/A	2021-03-16
Z-1589-2021	Class II	REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber...	Abbott Medical	N/A	2021-03-16
Z-1588-2021	Class II	REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros"...	Abbott Medical	N/A	2021-03-16
Z-1587-2021	Class II	REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage...	Abbott Medical	N/A	2021-03-16
Z-1586-2021	Class II	REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros...	Abbott Medical	N/A	2021-03-16
Z-1585-2021	Class II	REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the...	Abbott Medical	N/A	2021-03-16
Z-1584-2021	Class II	REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product...	Abbott Medical	N/A	2021-03-16
Z-1583-2021	Class II	REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV...	Abbott Medical	N/A	2021-03-16
Z-1582-2021	Class II	REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV...	Abbott Medical	N/A	2021-03-16
Z-1581-2021	Class II	REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the...	Abbott Medical	N/A	2021-03-16
Z-1580-2021	Class II	REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple...	Abbott Medical	ONB	2021-03-16
Z-1579-2021	Class II	REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros"...	Abbott Medical	ONB	2021-03-16