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 447 of 1190

FDA device recalls, page 447 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-3236-2018	Class II	Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3235-2018	Class II	Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3234-2018	Class II	Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3233-2018	Class II	Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3232-2018	Class II	Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3231-2018	Class II	AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and...	Philips North America LLC	OWB	2018-07-16
Z-3230-2018	Class II	AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3229-2018	Class II	AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3228-2018	Class II	AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3227-2018	Class II	Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3226-2018	Class II	AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3225-2018	Class II	Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3224-2018	Class II	Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3223-2018	Class II	Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3222-2018	Class II	Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3221-2018	Class II	Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3220-2018	Class II	NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3219-2018	Class II	INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-3218-2018	Class II	INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3217-2018	Class II	INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and...	Philips North America LLC	IZI	2018-07-16
Z-3216-2018	Class II	INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and...	Philips North America LLC	IZI	2018-07-16
Z-3215-2018	Class II	INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging...	Philips North America LLC	IZI	2018-07-16
Z-3214-2018	Class II	INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and...	Philips North America LLC	IZI	2018-07-16
Z-3213-2018	Class II	INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular...	Philips North America LLC	IZI	2018-07-16
Z-0104-2019	Class II	Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each...	Valeris Medical	MBI	2018-07-16
Z-2880-2018	Class II	CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product...	In2bones USA, LLC	HWC	2018-07-16
Z-2879-2018	Class II	CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product...	In2bones USA, LLC	HWC	2018-07-16
Z-2944-2018	Class II	Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612...	Roche Diagnostics GmbH	JQP	2018-07-16
Z-2930-2018	Class II	RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care...	Siemens Healthcare Diagnostics Inc.	GKR	2018-07-16
Z-2929-2018	Class II	RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care...	Siemens Healthcare Diagnostics Inc.	GKR	2018-07-16
Z-2928-2018	Class II	RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is...	Siemens Healthcare Diagnostics Inc.	GKR	2018-07-16
Z-2927-2018	Class II	RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999...	Siemens Healthcare Diagnostics Inc.	GKR	2018-07-16
Z-1721-2019	Class II	Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution	Sybron Dental Specialties, Inc.	MED	2018-07-13
Z-3195-2018	Class II	2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2018-07-13
Z-3194-2018	Class II	2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2018-07-13
Z-2951-2018	Class II	Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The...	Haemonetics Corporation	CAC	2018-07-13
Z-2950-2018	Class II	Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic...	Haemonetics Corporation	CAC	2018-07-13
Z-2966-2018	Class II	Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle...	Exactech, Inc.	LXH	2018-07-13
Z-2896-2018	Class II	Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs...	Philips North America LLC	MHX	2018-07-13
Z-2895-2018	Class II	Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 8...	Philips North America LLC	MHX	2018-07-13
Z-2894-2018	Class II	Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs...	Philips North America LLC	MHX	2018-07-13
Z-2893-2018	Class II	Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The...	Philips North America LLC	MHX	2018-07-13
Z-2892-2018	Class II	Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of...	Philips North America LLC	MHX	2018-07-13
Z-3196-2018	Class III	Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and...	Abbott Medical	JKA	2018-07-13
Z-3244-2018	Class II	G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the...	Tosoh Bioscience Inc	LCP	2018-07-13
Z-0776-2019	Class II	Revolution CT systems with the SmartStep Option The system is intended for head, whole...	GE Healthcare	JAK	2018-07-12
Z-0690-2019	Class II	Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool...	Ultradent Products Inc.	LBH	2018-07-12
Z-0087-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.	Orthosensor, Inc.	ONN	2018-07-12
Z-0086-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.	Orthosensor, Inc.	ONN	2018-07-12
Z-0085-2019	Class II	OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.	Orthosensor, Inc.	ONN	2018-07-12