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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 709 of 1191

FDA device recalls, page 709 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1659-2014	Class II	ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.	Siemens Healthcare Diagnostics Inc.	NTM	2014-04-10
Z-1658-2014	Class II	ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended...	Siemens Healthcare Diagnostics Inc.	MRG	2014-04-10
Z-1657-2014	Class II	ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended...	Siemens Healthcare Diagnostics Inc.	MRG	2014-04-10
Z-1656-2014	Class II	ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for...	Siemens Healthcare Diagnostics Inc.	MRG	2014-04-10
Z-1655-2014	Class II	ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material...	Siemens Healthcare Diagnostics Inc.	JLW	2014-04-10
Z-1654-2014	Class II	ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens...	Siemens Healthcare Diagnostics Inc.	JLW	2014-04-10
Z-1653-2014	Class II	ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens...	Siemens Healthcare Diagnostics Inc.	JLW	2014-04-10
Z-1639-2014	Class I	Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2014-04-10
Z-1699-2014	Class II	Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue...	Cochlear Americas	LXB	2014-04-09
Z-1489-2014	Class II	ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF...	Medtronic, Inc.	DQY	2014-04-09
Z-1467-2014	Class II	Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating...	Edwards Lifesciences LLC	DWF	2014-04-09
Z-1466-2014	Class II	Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes...	Edwards Lifesciences LLC	DWF	2014-04-09
Z-1640-2014	Class II	GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The...	GE Healthcare	KOI	2014-04-09
Z-1524-2015	Class II	MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo...	Siemens Healthcare Diagnostics Inc.	JWY	2014-04-08
Z-0914-2015	Class II	e.cam -emission computed tomography system Used to detect or image the distribution of...	Siemens Medical Solutions USA, Inc.	KPS	2014-04-08
Z-1537-2014	Class II	Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154...	Bio-Rad Laboratories Inc.	JPD	2014-04-08
Z-1681-2014	Class II	Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL...	Synthes GmbH	MQP	2014-04-08
Z-0508-2015	Class II	Intended for both adult and pediatric patients for taking diagnostic radiographic...	Philips North America LLC	IZL	2014-04-08
Z-1849-2014	Class II	Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)	Western Enterprises, Inc.	CAN	2014-04-07
Z-1873-2014	Class II	Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose...	JAS Diagnostics/Drew Scientific	CGA	2014-04-07
Z-1720-2014	Class II	SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for...	Small Bone Innovations, Inc.	KTT	2014-04-07
Z-1511-2014	Class II	GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d)...	GE Healthcare	LLZ	2014-04-07
Z-0131-2015	Class II	Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.	Abbott Medical	CHI	2014-04-07
Z-1527-2014	Class III	PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1...	Laurimed, LLC	ERL	2014-04-07
Z-1850-2014	Class II	Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700...	STERIS Corporation	FSY	2014-04-04
Z-1637-2014	Class II	TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF...	Smith & Nephew, Inc.	JDS	2014-04-04
Z-1636-2014	Class II	TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202...	Smith & Nephew, Inc.	JDS	2014-04-04
Z-1568-2014	Class II	Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic...	Medtronic Neuromodulation	LKK	2014-04-04
Z-1536-2014	Class II	Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human...	Becton, Dickinson and Company, BD Biosciences	MVU	2014-04-04
Z-1628-2014	Class II	Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The...	Philips North America LLC	MHX	2014-04-04
Z-1245-2015	Class II	AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and...	Baxter Healthcare Corporation	FIK	2014-04-03
Z-1673-2014	Class II	Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR...	Bayer Corp	FRN	2014-04-03
Z-1622-2014	Class II	syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS)...	Siemens Medical Solutions USA, Inc.	LLZ	2014-04-03
Z-1665-2014	Class II	The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis...	GE Healthcare	LLZ	2014-04-03
Z-1666-2014	Class II	Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of...	B Braun Medical Inc	BSP	2014-04-03
Z-1487-2014	Class II	iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound...	Boston Scientific Corporation	IYN	2014-04-03
Z-1613-2014	Class II	Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended...	Siemens Medical Solutions USA, Inc.	LLZ	2014-04-03
Z-1569-2014	Class II	Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is...	Shimadzu Medical Systems	IZI	2014-04-03
Z-1551-2014	Class II	Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part...	GE Healthcare	FMT	2014-04-02
Z-1550-2014	Class II	Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat...	GE Healthcare	FMT	2014-04-02
Z-1549-2014	Class II	Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared...	GE Healthcare	FMT	2014-04-02
Z-1548-2014	Class II	Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to...	GE Healthcare	FMT	2014-04-02
Z-1547-2014	Class II	Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to...	GE Healthcare	FMT	2014-04-02
Z-1504-2014	Class II	Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02...	Siemens Medical Solutions USA, Inc.	IYN	2014-04-02
Z-1480-2014	Class II	GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM...	GE Healthcare	LNH	2014-04-02
Z-2677-2014	Class II	Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys...	Genesys Spine	NKB	2014-04-02
Z-1566-2014	Class I	ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition)...	Baxter Corporation Englewood	NEP	2014-04-02
Z-1495-2014	Class II	Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that...	Philips North America LLC	LLZ	2014-04-02
Z-1438-2014	Class II	Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or...	Philips North America LLC	MKJ	2014-04-02
Z-0599-2016	Class III	NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.	Nipro Medical Corporation	FOZ	2014-04-01