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 2026-10-05, the FDA export date. FDA medical device recall database

59,336 records, page 1165 of 1187

FDA device recalls, page 1165 of 1187
Recall number	Product	Recalling firm	Product code	Initiated
Z-0272-04	Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #...	Edwards Lifesciences Technology SARL	FOZ	2003-10-08
Z-0113-04	Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0112-04	Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0111-04	DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0110-04	Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0109-04	Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0108-04	ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular...	Anika Therapeutics, Inc.	LZP	2003-10-08
Z-0048-04	Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length...	Wilson-Cook Medical Inc.	FEG	2003-10-08
Z-1116-04	Synchron LX Clinical Systems Software	Siemens Healthcare Diagnostics Inc.		2003-10-07
Z-0114-04	Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per...	MEDLINE INDUSTRIES, LP - Northfield	KKX	2003-10-07
Z-0087-04	RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649	Boston Scientific Corporation	GEI	2003-10-06
Z-0947-05	Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter...	Baxter Healthcare Renal Div	KDI	2003-10-03
Z-1153-04	Synchron Systems Lipid Calibrator (HDLD) Part 650218	Siemens Healthcare Diagnostics Inc.	JIS	2003-10-03
Z-0078-04	LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to...	E.M.S. - Electro Medical Systems SA	FFK	2003-10-03
Z-1025-04	Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas	Ascension Orthopedics, Inc.	NEG	2003-10-02
Z-0311-04	Introducer Sheath is indicated for patients requiring introduction of catheters...	Heartport, Inc.	DWF	2003-10-02
Z-0310-04	SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary...	Heartport, Inc.	DWF	2003-10-02
Z-0309-04	DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary...	Heartport, Inc.	DWF	2003-10-02
Z-0308-04	EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients...	Heartport, Inc.	DWF	2003-10-02
Z-0069-04	Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat...	Remel Inc	JTY	2003-10-02
Z-0307-04	EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients...	Heartport, Inc.	DWF	2003-10-02
Z-0064-04	ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST...	Acist Medical Systems, Inc.	DXT	2003-10-02
Z-0106-04	Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT	Siemens Medical Solutions USA, Inc.	KPS	2003-10-02
Z-0056-04	Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM...	Western Enterprises, Inc.	BZD	2003-10-02
Z-0055-04	Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM...	Western Enterprises, Inc.	BZD	2003-10-02
Z-0054-04	Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM...	Western Enterprises, Inc.	BZD	2003-10-02
Z-0142-04	Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free...	Merit Medical Systems, Inc.	DQO	2003-10-01
Z-0141-04	Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free...	Merit Medical Systems, Inc.	DQO	2003-10-01
Z-0140-04	Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free...	Merit Medical Systems, Inc.	DQO	2003-10-01
Z-0139-04	VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE...	Merit Medical Systems, Inc.	FMF	2003-10-01
Z-0138-04	IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in...	Merit Medical Systems, Inc.	DXT	2003-10-01
Z-0137-04	Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL...	Merit Medical Systems, Inc.	DXT	2003-10-01
Z-0809-04	RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer...	Centerpulse Orthopedics, Inc.	LZO	2003-09-30
Z-0091-04	AEROSET System Software version 1.02ER000	Abbott Medical	JQP	2003-09-30
Z-0771-04	Coag-A-Mate MTX and MTX II Instrument Operator Manual	bioMerieux, Inc.	GKP	2003-09-29
Z-0071-04	PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with...	Boston Scientific Corporation	DQX	2003-09-29
Z-0180-04	ComfortGel Nasal Mask size large	Respironics, Inc.	BZD	2003-09-29
Z-0179-04	ComfortGel Nasal Mask size medium	Respironics, Inc.	BZD	2003-09-29
Z-0178-04	ComfortGel Nasal Mask size small	Respironics, Inc.	BZD	2003-09-29
Z-0067-04	Synchron CX4, CX5 and CX9 Pro Systems.	Siemens Healthcare Diagnostics Inc.	JQP	2003-09-29
Z-0567-04	This device is labeled as Sterile and is packaged in a Tyvek pouch with the following...	Cordis US Corp.	MAF	2003-09-26
Z-0566-04	The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation...	Cordis US Corp.	MAF	2003-09-26
Z-0066-04	Bayer Rapidpoint 405 Blood Gas Analyzer	Siemens Healthcare Diagnostics Inc.	CHL	2003-09-26
Z-0235-04	Calculator/ Data Processing Module for Clinical Use.	CliniSys, Inc	JQP	2003-09-25
Z-0065-04	CryoValve, Pulmonary Heart Valve	Artivion, Inc.	MIE	2003-09-25
Z-0104-04	ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility...	Diversatek Healthcare Inc	FFT	2003-09-24
Z-0086-04	Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037	Concentric Medical, Inc.	DQY	2003-09-24
Z-0085-04	Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035	Concentric Medical, Inc.	DQY	2003-09-24
Z-0077-04	Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1...	BIOTRONIK AG	LWS	2003-09-24
Z-0076-04	Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer...	BIOTRONIK AG	LWS	2003-09-24