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 698 of 1191

FDA device recalls, page 698 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1815-2014	Class I	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating...	Confluent Medical Technologies, Inc	DQX	2014-05-28
Z-1814-2014	Class I	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating...	Confluent Medical Technologies, Inc	DQX	2014-05-28
Z-1813-2014	Class I	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating...	Confluent Medical Technologies, Inc	DQX	2014-05-28
Z-1812-2014	Class I	HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating...	Confluent Medical Technologies, Inc	DQX	2014-05-28
Z-1847-2014	Class II	Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for...	Baxter Corporation Englewood	NEP	2014-05-28
Z-1981-2014	Class I	Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston...	Vascular Solutions LLC	DQO	2014-05-27
Z-2133-2014	Class III	Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human...	Siemens Healthcare Diagnostics Inc.	JJE	2014-05-27
Z-1843-2014	Class II	FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood...	BioFire Diagnostics, LLC	PAM	2014-05-27
Z-2155-2014	Class I	CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System...	Cardiovascular Systems Incorporated	MCW	2014-05-23
Z-2106-2014	Class II	CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2105-2014	Class II	Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2079-2014	Class II	RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge...	Siemens Healthcare Diagnostics Inc.	KHP	2014-05-23
Z-2035-2014	Class II	Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4...	Zimmer GmbH	LPH	2014-05-23
Z-2034-2014	Class II	Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4...	Zimmer GmbH	LPH	2014-05-23
Z-2033-2014	Class II	Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0...	Zimmer GmbH	LPH	2014-05-23
Z-2104-2014	Class II	Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8"...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2103-2014	Class II	Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2102-2014	Class II	Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2101-2014	Class II	Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2100-2014	Class II	Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2099-2014	Class II	Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer &...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2098-2014	Class II	Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2097-2014	Class II	Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2096-2014	Class II	Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2"...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2095-2014	Class II	Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-2094-2014	Class II	Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without...	Terumo Cardiovascular Systems Corporation	DWF	2014-05-23
Z-1851-2014	Class II	RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical...	Teleflex Medical	BTR	2014-05-23
Z-1800-2014	Class II	MOSAIQ, an oncology information system used to manage workflows for treatment planning...	Elekta Limited	IYE	2014-05-23
Z-1808-2014	Class II	GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX...	GE Healthcare	CCL	2014-05-23
Z-1638-2015	Class II	GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)	GE Healthcare	OXO	2014-05-22
Z-2071-2014	Class III	Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages...	Siemens Healthcare Diagnostics Inc.	JQP	2014-05-22
Z-1780-2014	Class II	Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices...	Stryker Corp.	HBE	2014-05-22
Z-1779-2014	Class II	Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to...	Stryker Corp.	HBE	2014-05-22
Z-1778-2014	Class II	Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1777-2014	Class II	Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1776-2014	Class II	Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1775-2014	Class II	Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1774-2014	Class II	Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1773-2014	Class II	Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1772-2014	Class II	Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1771-2014	Class II	Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used...	Stryker Corp.	HBE	2014-05-22
Z-1770-2014	Class II	Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to...	Stryker Corp.	HBE	2014-05-22
Z-1769-2014	Class II	Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to...	Stryker Corp.	HBE	2014-05-22
Z-1768-2014	Class II	Stryker 5.0mm Barrel Bur Sterile	Stryker Corp.	HBE	2014-05-22
Z-1767-2014	Class II	Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut...	Stryker Corp.	HBE	2014-05-22
Z-1766-2014	Class II	Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut...	Stryker Corp.	HBE	2014-05-22
Z-1765-2014	Class II	Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1764-2014	Class II	Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1763-2014	Class II	Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1762-2014	Class II	Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22