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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 588 of 1191

FDA device recalls, page 588 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1697-2017	Class II	iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for...	Merge Healthcare Incorporated	LMB	2016-04-04
Z-1828-2017	Class II	Merge Eye Station and Merge Eye Care PACS.	Merge Healthcare Incorporated	NFJ	2016-04-04
Z-1700-2017	Class II	iConnect Enterprise Archive software.	Merge Healthcare Incorporated	LMB	2016-04-04
Z-1470-2017	Class II	iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge...	Merge Healthcare Incorporated	LMB	2016-04-04
Z-1431-2017	Class II	Merge PACS software. The firm name on the label is Merge Healthcare.	Merge Healthcare Incorporated	LLZ	2016-04-04
Z-1403-2017	Class II	Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2016-04-04
Z-1457-2017	Class II	Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that...	Merge Healthcare Incorporated	DQK	2016-04-04
Z-1486-2017	Class II	Merge Cardio software.	Merge Healthcare Incorporated	LLZ	2016-04-04
Z-1415-2017	Class II	Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare...	Merge Healthcare Incorporated	LLZ	2016-04-04
Z-1498-2017	Class II	Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge...	Merge Healthcare Incorporated	OUG	2016-04-04
Z-1681-2017	Class II	Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge...	Merge Healthcare Incorporated	NFJ	2016-04-04
Z-1176-2017	Class II	Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2016-04-04
Z-1104-2017	Class II	ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus...	Mesa Laboratories Inc	FRC	2016-04-04
Z-1626-2016	Class II	Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular...	Stryker Sustainability Solutions	BTR	2016-04-04
Z-1625-2016	Class II	Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175	Stryker Sustainability Solutions	BTR	2016-04-04
Z-1574-2016	Class II	5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #...	Synthes (USA) Products LLC	HWC	2016-04-04
Z-2118-2016	Class II	Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core...	Philips North America LLC	JAK	2016-04-01
Z-2117-2016	Class II	Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core...	Philips North America LLC	JAK	2016-04-01
Z-2116-2016	Class II	Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64...	Philips North America LLC	JAK	2016-04-01
Z-1828-2016	Class II	Various trauma and sports medicine instruments and implants. Fastener, fixation...	Zimmer GmbH	MBI	2016-04-01
Z-1827-2016	Class II	Various trauma and sports medicine instruments and implants. Orthopedic manual surgical...	Zimmer GmbH	LXH	2016-04-01
Z-1826-2016	Class II	Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation...	Zimmer GmbH	KWP	2016-04-01
Z-1825-2016	Class II	Various trauma and sports medicine instruments and implants. Appliance, fixation...	Zimmer GmbH	KTT	2016-04-01
Z-1824-2016	Class II	Various trauma and sports medicine instruments and implants. Passer.	Zimmer GmbH	HWQ	2016-04-01
Z-1823-2016	Class II	Various trauma and sports medicine instruments and implants. Screw, fixation, bone.	Zimmer GmbH	HWC	2016-04-01
Z-1822-2016	Class II	Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.	Zimmer GmbH	HTY	2016-04-01
Z-1821-2016	Class II	Various trauma and sports medicine instruments and implants. Bit, drill.	Zimmer GmbH	HTW	2016-04-01
Z-1820-2016	Class II	Various trauma and sports medicine instruments and implants. Reamer.	Zimmer GmbH	HTO	2016-04-01
Z-1819-2016	Class II	Various trauma and sports medicine instruments and implants. Rod, fixation...	Zimmer GmbH	HSB	2016-04-01
Z-1818-2016	Class II	Various trauma and sports medicine instruments and implants. Arthroscope.	Zimmer GmbH	HRX	2016-04-01
Z-1817-2016	Class II	Various trauma and sports medicine instruments and implants. Plate, fixation, bone.	Zimmer GmbH	HRS	2016-04-01
Z-1816-2016	Class II	Various trauma and sports medicine instruments and implants. cannula, surgical, general &...	Zimmer GmbH	GEA	2016-04-01
Z-1815-2016	Class II	Various trauma and sports medicine instruments and implants. guide, surgical, instrument	Zimmer GmbH	FZX	2016-04-01
Z-1558-2016	Class II	SOMATOM Force, Computed Tomography x-ray system intended to generate and process...	Siemens Medical Solutions USA, Inc.	JAK	2016-04-01
Z-1536-2016	Class I	Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be...	B Braun Medical Inc	KDI	2016-04-01
Z-1535-2016	Class I	Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can...	B Braun Medical Inc	KDI	2016-04-01
Z-1534-2016	Class I	Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code #...	B Braun Medical Inc	KDI	2016-04-01
Z-1533-2016	Class I	Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code #...	B Braun Medical Inc	KDI	2016-04-01
Z-1532-2016	Class I	Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial #...	B Braun Medical Inc	KDI	2016-04-01
Z-1531-2016	Class I	Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318...	B Braun Medical Inc	KDI	2016-04-01
Z-1621-2016	Class II	Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels...	Applied Medical Resources Corp	FZP	2016-04-01
Z-1649-2016	Class II	Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to...	Medtronic, Inc.	LZH	2016-04-01
Z-1648-2016	Class II	Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to...	Medtronic, Inc.	LZH	2016-04-01
Z-1599-2016	Class II	Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU	FUJIFILM Healthcare Americas Corporation	IXW	2016-04-01
Z-2898-2020	Class II	E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image...	Siemens Medical Solutions USA, Inc.	KPS	2016-03-31
Z-1811-2016	Class II	Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and...	American Surgical Company, LLC	LZB	2016-03-31
Z-1810-2016	Class II	American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and...	American Surgical Company, LLC		2016-03-31
Z-1809-2016	Class II	American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and...	American Surgical Company, LLC	HBA	2016-03-31
Z-1808-2016	Class II	American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and...	American Surgical Company, LLC	HBA	2016-03-31
Z-1807-2016	Class II	American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and...	American Surgical Company, LLC	HBA	2016-03-31