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 415 of 1190

FDA device recalls, page 415 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1051-2019	Class II	BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a...	Becton Dickinson & Co	JQP	2019-02-21
Z-2425-2019	Class II	FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1	Karl Storz Endoscopy-America, Inc.	GWG	2019-02-20
Z-2288-2019	Class II	ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073	Luminex Corporation	OOI	2019-02-20
Z-2287-2019	Class II	ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059	Luminex Corporation	OZN	2019-02-20
Z-2286-2019	Class II	ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469	Luminex Corporation	PGX	2019-02-20
Z-2285-2019	Class II	ARIES GBS Assay , REF 50-10021, UDI # 00840487100165	Luminex Corporation	NJR	2019-02-20
Z-2284-2019	Class II	ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158	Luminex Corporation	OZE	2019-02-20
Z-2283-2019	Class II	ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295	Luminex Corporation	PGI	2019-02-20
Z-2282-2019	Class II	Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452	Luminex Corporation	OZZ	2019-02-20
Z-1293-2019	Class II	VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in...	Ortho-Clinical Diagnostics, Inc.	KHO	2019-02-20
Z-1292-2019	Class II	VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro...	Ortho-Clinical Diagnostics, Inc.	KHO	2019-02-20
Z-1291-2019	Class II	VITROS XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-02-20
Z-1290-2019	Class II	VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-02-20
Z-1289-2019	Class II	VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-02-20
Z-1288-2019	Class II	VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-02-20
Z-1287-2019	Class II	VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-02-20
Z-1074-2019	Class II	CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated...	Abbott Medical	GKZ	2019-02-20
Z-3251-2026	Class II	Automated Impella Controller (AIC) with the below product descriptions and corresponding...	Abiomed, Inc.	OZD	2019-02-19
Z-0671-2020	Class II	Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent...	The Binding Site Group Ltd.	DCN	2019-02-19
Z-1141-2019	Class II	Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura...	Philips Medical Systems Nederland B.V.	IZI	2019-02-19
Z-1140-2019	Class II	Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes...	Philips Medical Systems Nederland B.V.	IZI	2019-02-19
Z-1088-2019	Class III	Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is a sharp...	Becton Dickinson & Co	HNN	2019-02-19
Z-1029-2019	Class II	smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM...	Smith & Nephew, Inc.	LPH	2019-02-19
Z-1028-2019	Class II	smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM...	Smith & Nephew, Inc.	LPH	2019-02-19
Z-0718-2020	Class II	LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X...	Bard Peripheral Vascular Inc	PRL	2019-02-18
Z-1506-2020	Class II	DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products...	Tedan Surgical Innovations, Inc.	LXH	2019-02-18
Z-1505-2020	Class II	DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products...	Tedan Surgical Innovations, Inc.	LXH	2019-02-18
Z-1504-2020	Class II	D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction...	Tedan Surgical Innovations, Inc.	LXH	2019-02-18
Z-1503-2020	Class II	D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction...	Tedan Surgical Innovations, Inc.	LXH	2019-02-18
Z-1047-2019	Class II	Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone...	Avitus Orthopaedics, Inc	KNW	2019-02-18
Z-1046-2019	Class II	Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and...	Avitus Orthopaedics, Inc	KNW	2019-02-18
Z-0692-2020	Class III	QuickTox 5 Panel Drug Screen DipCard	Ameditech, Inc.	DJG	2019-02-15
Z-2475-2019	Class II	Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the...	Alere San Diego, Inc.	JJE	2019-02-15
Z-1041-2019	Class II	Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736	Medtronic, Inc.	JOW	2019-02-15
Z-1020-2019	Class II	Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical...	Medtronic, Inc.	GEI	2019-02-15
Z-0582-2020	Class II	PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended...	Bard Peripheral Vascular Inc	LJT	2019-02-14
Z-1247-2019	Class II	SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual...	Siemens Medical Solutions USA, Inc.	JAK	2019-02-14
Z-1246-2019	Class II	SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems...	Siemens Medical Solutions USA, Inc.	JAK	2019-02-14
Z-1245-2019	Class II	SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography...	Siemens Medical Solutions USA, Inc.	JAK	2019-02-14
Z-1033-2019	Class II	Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product...	ACell, Inc	FTM	2019-02-14
Z-1032-2019	Class II	Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product...	ACell, Inc	FTM	2019-02-14
Z-1244-2019	Class II	SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems...	Siemens Medical Solutions USA, Inc.	JAK	2019-02-14
Z-1148-2019	Class II	BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use...	Bioventus LLC	MQV	2019-02-13
Z-1057-2019	Class II	Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of...	Randox Laboratories, Limited	JJY	2019-02-13
Z-1750-2019	Class II	Discovery Ml DR Product Usage: The systems are intended for head and whole body...	GE Healthcare	KPS	2019-02-12
Z-1749-2019	Class II	Discovery Ml Product Usage: The systems are intended for head and whole body...	GE Healthcare	KPS	2019-02-12
Z-1748-2019	Class II	Discovery IQ Product Usage: The systems are intended for head and whole body...	GE Healthcare	KPS	2019-02-12
Z-1747-2019	Class II	Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole...	GE Healthcare	KPS	2019-02-12
Z-1746-2019	Class II	Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body...	GE Healthcare	KPS	2019-02-12
Z-1745-2019	Class II	Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body...	GE Healthcare	KPS	2019-02-12