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 566 of 1191

FDA device recalls, page 566 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0846-2017	Class II	BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0845-2017	Class II	BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0844-2017	Class II	BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0843-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0842-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0841-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0840-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0839-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0838-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0837-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0836-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0835-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0834-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0833-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0832-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0831-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0830-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 30 ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0829-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0828-2017	Class II	BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant...	ZimVie US Corp LLC	NHA	2016-09-14
Z-0136-2017	Class II	Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture...	Hand Biomechanics Lab Inc	JEC	2016-09-14
Z-0586-2017	Class II	Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016	Roche Diabetes Care, Inc.	NDC	2016-09-14
Z-0077-2017	Class II	Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits...	Varian Medical Systems, Inc.	IYE	2016-09-13
Z-0302-2017	Class II	ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US...	TEM Systems Inc	JPA	2016-09-13
Z-0093-2017	Class II	LipiFlow thermal Pulsation System, consisting of Console and Activator, Model...	TearScience, Inc.	ORZ	2016-09-13
Z-0063-2017	Class II	Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who...	A and D Engineering, Inc.	DXN	2016-09-12
Z-0389-2017	Class II	SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD...	Akita Sumitomo Bakelite Co., Ltd.	KNS	2016-09-09
Z-0388-2017	Class II	SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD...	Akita Sumitomo Bakelite Co., Ltd.	KNS	2016-09-09
Z-0080-2017	Class II	Zero-Gravity Radiation Protection System Radiology Personnel protective shield.	Domico Med-Device, LLC	EAJ	2016-09-09
Z-0059-2017	Class II	Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured...	Teleflex Medical	GCJ	2016-09-09
Z-0058-2017	Class II	Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile...	Teleflex Medical	GCJ	2016-09-09
Z-0051-2017	Class II	MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath...	Argon Medical Devices, Inc	DYB	2016-09-08
Z-0623-2017	Class II	Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial...	Greatbatch Medical	DYB	2016-09-08
Z-0321-2017	Class II	TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD...	Datascope Corp.	MHX	2016-09-08
Z-0748-2017	Class II	ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable...	Ellman International, Inc.	GEI	2016-09-07
Z-0075-2017	Class II	Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use...	Banyan Medical, LLC	GCJ	2016-09-07
Z-0074-2017	Class II	Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use...	Banyan Medical, LLC	GCJ	2016-09-07
Z-1137-2017	Class II	Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following...	Boston Scientific Corporation	LJW	2016-09-07
Z-0050-2017	Class II	IgE Calibrator Series	Randox Laboratories, Limited	DGC	2016-09-07
Z-0300-2017	Class II	enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific...	Ortho-Clinical Diagnostics, Inc.	JJE	2016-09-07
Z-0113-2017	Class II	Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable...	Osteogenics Biomedical, Inc.	LYC	2016-09-07
Z-2892-2016	Class II	Syngo.plaza VB10A, Picture Archiving and Communication System	Siemens Medical Solutions USA, Inc.	LLZ	2016-09-06
Z-2891-2016	Class II	Syngo.plaza, Picture Archiving and Communication System	Siemens Medical Solutions USA, Inc.	LLZ	2016-09-06
Z-2900-2016	Class II	AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	OYE	2016-09-06
Z-0978-2017	Class II	Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular...	Alcon Laboratories	MSS	2016-09-05
Z-0353-2020	Class II	2000 Vascular with 30 Degree option	Heritage Medical Products, Inc	LGX	2016-09-02
Z-0331-2017	Class II	HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DQO	2016-09-02
Z-0609-2017	Class II	Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled...	Trilliant Surgical LLC	HWC	2016-09-02
Z-2913-2016	Class III	Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322...	Siemens Healthcare Diagnostics Inc.	JFS	2016-09-02
Z-2912-2016	Class III	Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161	Siemens Healthcare Diagnostics Inc.	JFS	2016-09-02
Z-2085-2019	Class II	VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144	CellEra, LLC	NAE	2016-09-01