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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 740 of 1191

FDA device recalls, page 740 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2219-2013	Class II	BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable...	Smith & Nephew, Inc.	HWC	2013-08-06
Z-2218-2013	Class II	BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number...	Smith & Nephew, Inc.	HWC	2013-08-06
Z-2217-2013	Class II	BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number...	Smith & Nephew, Inc.	HWC	2013-08-06
Z-2216-2013	Class II	BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number...	Smith & Nephew, Inc.	HWC	2013-08-06
Z-2215-2013	Class II	BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number...	Smith & Nephew, Inc.	HWC	2013-08-06
Z-0122-2014	Class II	Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging	Canon Medical Systems USA, Inc.	IYN	2013-08-05
Z-0121-2014	Class II	Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging	Canon Medical Systems USA, Inc.	IYN	2013-08-05
Z-0120-2014	Class II	Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging	Canon Medical Systems USA, Inc.	IYN	2013-08-05
Z-0119-2014	Class II	Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging	Canon Medical Systems USA, Inc.	IYN	2013-08-05
Z-2242-2013	Class II	3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and...	3M Company	ITG	2013-08-05
Z-2166-2013	Class II	Outlook Safety Infusion System Burette Set. For intravenous fluid administration.	B Braun Medical Inc	FRN	2013-08-05
Z-2100-2013	Class II	3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150...	3M ESPE Dental Products	ELZ	2013-08-05
Z-1984-2013	Class II	Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and...	Medicel AG	HQL	2013-08-05
Z-2160-2013	Class II	Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems...	Acteon, Inc.	KXJ	2013-08-02
Z-1994-2013	Class II	Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and...	Getinge USA, Inc.	FRC	2013-08-02
Z-0429-2014	Class II	Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy...	Synthes GmbH	GAD	2013-08-01
Z-2046-2013	Class II	NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5...	Nidek Incorporated	HKI	2013-08-01
Z-2055-2013	Class II	00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile...	Zimmer GmbH	KWT	2013-08-01
Z-0387-2014	Class II	Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress...	Synthes GmbH	HSB	2013-07-31
Z-0388-2014	Class II	Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended...	Synthes GmbH	LXH	2013-07-31
Z-0384-2014	Class II	Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical...	Synthes GmbH	LXH	2013-07-31
Z-0408-2014	Class II	Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation...	Synthes GmbH	HTW	2013-07-31
Z-0380-2014	Class II	2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of...	Synthes GmbH	HRS	2013-07-31
Z-0112-2014	Class II	Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of...	FUJIFILM Healthcare Americas Corporation	FDS	2013-07-31
Z-0717-2014	Class II	Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems...	Leica Biosystems Newcastle Ltd.	NJT	2013-07-31
Z-2258-2013	Class II	VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations...	Spine Smith Partners L.P.	MAX	2013-07-31
Z-2189-2013	Class II	"*Flo Trac Sensor Model MHD85*" Sterile, single use kit that monitors pressures when...	Edwards Lifesciences LLC	DRS	2013-07-31
Z-2138-2013	Class II	Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1)...	Boston Scientific Corporation	LIT	2013-07-31
Z-2137-2013	Class II	Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation...	Boston Scientific Corporation	LIT	2013-07-31
Z-0097-2014	Class II	PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are...	DePuy Spine, Inc.	GCC	2013-07-31
Z-0096-2014	Class II	PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and...	DePuy Spine, Inc.	GCC	2013-07-31
Z-0095-2014	Class II	PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and...	DePuy Spine, Inc.	GCC	2013-07-31
Z-0094-2014	Class II	PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and...	DePuy Spine, Inc.	GCC	2013-07-31
Z-0093-2014	Class II	PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and...	DePuy Spine, Inc.	GCC	2013-07-31
Z-1965-2013	Class II	Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQY	2013-07-31
Z-0818-2016	Class II	High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are...	Smith & Nephew, Inc.	NBH	2013-07-30
Z-0407-2014	Class II	Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and...	Synthes GmbH	JDS	2013-07-30
Z-0409-2014	Class II	Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary...	Synthes GmbH	KTT	2013-07-30
Z-0452-2014	Class II	Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable...	Synthes GmbH	HSB	2013-07-30
Z-0410-2014	Class II	Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement...	Synthes GmbH	OAR	2013-07-30
Z-0406-2014	Class II	Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures...	Synthes (USA) Products LLC	HRS	2013-07-30
Z-0474-2014	Class II	Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail...	Synthes GmbH	HSB	2013-07-30
Z-0018-2014	Class II	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The...	Getinge Disinfection AB	MEC	2013-07-30
Z-0051-2014	Class II	Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number...	Synergetics Inc	HMX	2013-07-30
Z-2087-2013	Class II	Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage...	Synthes GmbH	HRS	2013-07-30
Z-2135-2013	Class II	ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME...	Siemens Healthcare Diagnostics Inc.	LCP	2013-07-30
Z-2101-2013	Class II	ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE...	Zimmer GmbH	HRS	2013-07-30
Z-1963-2013	Class II	Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512...	Edwards Lifesciences LLC	DWF	2013-07-30
Z-2054-2013	Class II	Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc)...	Stryker Craniomaxillofacial Division	GXP	2013-07-30
Z-2161-2013	Class II	Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda...	GE Healthcare	BSZ	2013-07-29