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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 484 of 1191

FDA device recalls, page 484 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0369-2018	Class II	ESSENTIO MRI SR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0368-2018	Class II	ESSENTIO DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0367-2018	Class II	ESSENTIO SR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0366-2018	Class II	VISIONIST X4 CRT-P Pacemaker	Boston Scientific Corporation	NKE	2017-12-07
Z-0365-2018	Class II	VISIONIST CRT-P Pacemaker	Boston Scientific Corporation	NKE	2017-12-07
Z-0364-2018	Class II	ALTRUA 2 EL DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0363-2018	Class II	ALTRUA 2 DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0362-2018	Class II	ALTRUA 2 SR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0361-2018	Class II	VALITUDE X4 CRT-P Pacemaker	Boston Scientific Corporation	NKE	2017-12-07
Z-0360-2018	Class II	VALITUDE CRT-P Pacemaker	Boston Scientific Corporation	NKE	2017-12-07
Z-0359-2018	Class II	ACCOLADE MRI EL DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0358-2018	Class II	ACCOLADE MRI DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0357-2018	Class II	ACCOLADE MRI SR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0356-2018	Class II	ACCOLADE EL DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0355-2018	Class II	ACCOLADE DR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-0354-2018	Class II	ACCOLADE SR Pacemaker	Boston Scientific Corporation	LWP	2017-12-07
Z-2442-2018	Class II	Health Harmony Mobile application software Product Usage: Care Innovations Health...	Intel-Ge Care Innovations, LLC	OUG	2017-12-06
Z-1318-2018	Class II	Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this...	Haag-Streit USA Inc	HKN	2017-12-06
Z-0352-2018	Class II	Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA...	Medtronic Sofamor Danek USA Inc	OAR	2017-12-06
Z-0934-2018	Class II	Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235...	Ion Beam Applications S.A.	LHN	2017-12-05
Z-2184-2018	Class II	CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products...	Cellavision AB	JOY	2017-12-04
Z-1893-2018	Class II	iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY...	Siemens Healthcare Diagnostics Inc.	LJX	2017-12-04
Z-1215-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588	Konica Minolta, Inc.	IYN	2017-12-04
Z-1214-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2...	Konica Minolta, Inc.	IYN	2017-12-04
Z-1213-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534	Konica Minolta, Inc.	IYN	2017-12-04
Z-1212-2018	Class II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031	Konica Minolta, Inc.	IYN	2017-12-04
Z-1279-2018	Class II	Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI...	Life Technologies Corporation	PQP	2017-12-04
Z-1074-2018	Class II	Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5...	Abbott Medical	LJT	2017-12-04
Z-1073-2018	Class II	PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL...	Abbott Medical	LJT	2017-12-04
Z-0822-2018	Class II	Truth Renew Plus	Accord Media	OLP	2017-12-04
Z-0821-2018	Class II	Ultra Renew Plus	Accord Media	OLP	2017-12-04
Z-0820-2018	Class II	Truth Renew	Accord Media	OLP	2017-12-04
Z-0819-2018	Class II	Ultra Renew	Accord Media	OLP	2017-12-04
Z-0294-2018	Class I	LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e...	Physio Control, Inc.	MKJ	2017-12-04
Z-0362-2019	Class II	Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7...	Fresenius Vial S.A.S.	FRN	2017-12-02
Z-0555-2018	Class II	VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications...	LivaNova USA, Inc.	LYJ	2017-12-02
Z-0319-2018	Class II	Sundream 12 V tanning bed	J&T Health and Wellness LLC	LEJ	2017-12-02
Z-2840-2018	Class II	ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S...	Elekta Limited	IYE	2017-12-01
Z-1644-2018	Class II	RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee...	Mako Surgical Corp.	OLO	2017-12-01
Z-1181-2018	Class II	Rotating IV Pole Rotating IV Pole falls under the category classified as capital...	GE Healthcare	FOX	2017-12-01
Z-1242-2018	Class III	Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas...	Datascope Corp.	BZK	2017-12-01
Z-0272-2018	Class II	3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast...	Stryker Sustainability Solutions	JOW	2017-12-01
Z-2379-2018	Class II	BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235...	Abbott Medical	CCK	2017-11-29
Z-1061-2018	Class II	GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR FEM SZ 2 RT...	Zimmer GmbH	MBH	2017-11-29
Z-1060-2018	Class II	GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT...	Zimmer GmbH	JWH	2017-11-29
Z-1059-2018	Class II	CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX...	Zimmer GmbH	JWH	2017-11-29
Z-1058-2018	Class II	CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ D-R...	Zimmer GmbH	JWH	2017-11-29
Z-1057-2018	Class II	NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT " These devices are indicated for...	Zimmer GmbH	MBH	2017-11-29
Z-1056-2018	Class II	Lps-Flex Gsf Opt Sz C-L Lps-Flex Gsf Opt Sz C-R Lps-Flex Gsf Opt Sz D-L Lps-Flex Gsf Opt...	Zimmer GmbH	JWH	2017-11-29
Z-1055-2018	Class II	FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+...	Zimmer GmbH	HSX	2017-11-29