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 565 of 1191

FDA device recalls, page 565 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1234-2017	Class II	CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile...	Custom Medical Specialties, Inc.	FCH	2016-09-20
Z-0766-2017	Class II	Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the...	Encore Medical, LP	JWH	2016-09-19
Z-0699-2017	Class II	Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers...	TORNIER Inc.	KWS	2016-09-19
Z-0651-2017	Class II	PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for...	Bausch & Lomb Incorporated	LPN	2016-09-19
Z-0293-2017	Class II	Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number...	Philips North America LLC	MHX	2016-09-19
Z-0292-2017	Class II	Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product...	Philips North America LLC	MHX	2016-09-19
Z-0324-2017	Class II	Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder...	Stryker Sustainability Solutions	KCY	2016-09-19
Z-0325-2017	Class II	Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of...	Encore Medical, LP	JWH	2016-09-19
Z-0291-2017	Class II	Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz)...	Philips North America LLC	MHX	2016-09-19
Z-2916-2016	Class II	ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation...	New Star Lasers, Inc.	GEX	2016-09-19
Z-2915-2016	Class II	VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision...	New Star Lasers, Inc.	GEX	2016-09-19
Z-2914-2016	Class II	CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in...	New Star Lasers, Inc.	GEX	2016-09-19
Z-2523-2018	Class II	Brivo XR385, model 5215463, Digital Diagnostic Radiographic System	GE Healthcare	KPR	2016-09-16
Z-2139-2018	Class II	Proteus ONE and Proteus Plus	Ion Beam Applications S.A.	LHN	2016-09-16
Z-2138-2018	Class II	12C	Ion Beam Applications S.A.	LHN	2016-09-16
Z-2753-2017	Class II	BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is...	Becton Dickinson & Co	FMF	2016-09-16
Z-2752-2017	Class II	BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe...	Becton Dickinson & Co	FMF	2016-09-16
Z-2751-2017	Class II	BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is...	Becton Dickinson & Co	FMF	2016-09-16
Z-2750-2017	Class II	BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x...	Becton Dickinson & Co	FMF	2016-09-16
Z-2749-2017	Class II	BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x...	Becton Dickinson & Co	FMF	2016-09-16
Z-2748-2017	Class II	BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to...	Becton Dickinson & Co	FMI	2016-09-16
Z-2747-2017	Class II	BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog...	Becton Dickinson & Co	FMF	2016-09-16
Z-0055-2017	Class I	Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with...	Vascular Solutions LLC	DQO	2016-09-16
Z-0054-2017	Class I	Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with...	Vascular Solutions LLC	DQY	2016-09-16
Z-0762-2017	Class II	The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls...	Randox Laboratories, Limited	JJY	2016-09-16
Z-0053-2017	Class I	Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230...	Vascular Solutions LLC	DQY	2016-09-16
Z-0290-2017	Class II	RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	2016-09-16
Z-0769-2017	Class II	Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy...	Natus Medical Incorporated	LBI	2016-09-16
Z-0652-2017	Class II	Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro...	Siemens Healthcare Diagnostics Inc.	JIX	2016-09-15
Z-0088-2017	Class II	SDMS (SenTec Digital Monitoring System)	Sentec AG	LKD	2016-09-15
Z-0299-2017	Class II	Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x...	Keystone Dental Inc.	DZE	2016-09-15
Z-0073-2017	Class II	Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version...	FUJIFILM Healthcare Americas Corporation	LLZ	2016-09-15
Z-0349-2017	Class II	Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large...	Battle Creek Equipment	IRT	2016-09-15
Z-0863-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0862-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0861-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0860-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0859-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0858-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0857-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0856-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0855-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0854-2017	Class II	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0853-2017	Class II	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0852-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0851-2017	Class II	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0850-2017	Class II	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0849-2017	Class II	BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0848-2017	Class II	BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0847-2017	Class II	BIOMET 3i LOW PROFILE 30 ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14