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 534 of 1191

FDA device recalls, page 534 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1818-2017	Class II	Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x...	Keystone Dental Inc.	DZE	2017-03-09
Z-1871-2017	Class II	SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr...	C.R. Bard Inc	EYZ	2017-03-09
Z-1736-2017	Class II	CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1735-2017	Class II	OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1734-2017	Class II	POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1733-2017	Class II	EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1732-2017	Class II	OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1731-2017	Class II	OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1730-2017	Class II	POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and...	Centurion Medical Products, LP	OXQ	2017-03-09
Z-1857-2017	Class II	D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X...	Smith & Nephew, Inc.	HWC	2017-03-09
Z-1856-2017	Class II	D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic	Smith & Nephew, Inc.	HWC	2017-03-09
Z-1855-2017	Class II	D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic	Smith & Nephew, Inc.	HWC	2017-03-09
Z-1854-2017	Class II	Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF...	Smith & Nephew, Inc.	HRS	2017-03-09
Z-1825-2017	Class II	Hemotherm CE, model 400CE, Heater-Cooling Device	Gentherm Medical, LLC	DWC	2017-03-09
Z-1695-2017	Class II	Proteus 235	Ion Beam Applications S.A.	LHN	2017-03-09
Z-1894-2017	Class II	Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V	Sonesta Medical AB	MMZ	2017-03-08
Z-1701-2017	Class II	BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray...	ZimVie US Corp LLC	DZE	2017-03-08
Z-1749-2017	Class II	Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF)...	Siemens Healthcare Diagnostics Inc.	MOI	2017-03-08
Z-1748-2017	Class II	Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR...	Siemens Healthcare Diagnostics Inc.	MOI	2017-03-08
Z-1747-2017	Class II	Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR...	Siemens Healthcare Diagnostics Inc.	MOI	2017-03-08
Z-1827-2017	Class II	Ferno PROFlexx Model 28Z Chair Cot	Ferno-Washington Inc	FPO	2017-03-08
Z-2077-2017	Class II	enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions...	Ortho-Clinical Diagnostics, Inc.	JJE	2017-03-08
Z-1870-2017	Class II	Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set	Cook Incorporated	FCS	2017-03-07
Z-1814-2017	Class II	AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent...	Aesculap Inc	GWG	2017-03-07
Z-1878-2017	Class II	uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended...	ulrich medical USA Inc	KWQ	2017-03-07
Z-1711-2017	Class II	UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product...	Siemens Healthcare Diagnostics Inc.	JJE	2017-03-07
Z-1710-2017	Class II	Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The...	Siemens Healthcare Diagnostics Inc.	JJE	2017-03-07
Z-1709-2017	Class II	Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI...	Siemens Healthcare Diagnostics Inc.	JJE	2017-03-07
Z-1713-2017	Class II	NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the...	bioMerieux, Inc.	PPM	2017-03-07
Z-1765-2017	Class II	VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD...	Ortho-Clinical Diagnostics, Inc.	NBC	2017-03-07
Z-1761-2017	Class II	Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended...	Wallac Oy	JQP	2017-03-07
Z-1689-2017	Class II	Syngo.via, Picture archiving and communication system Syngo via is a software solution...	Siemens Medical Solutions USA, Inc.	LLZ	2017-03-06
Z-1688-2017	Class II	Syngo.x, Picture archiving and communication system Syngo via is a software solution...	Siemens Medical Solutions USA, Inc.	LLZ	2017-03-06
Z-1707-2017	Class II	Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part...	Philips North America LLC	DSI	2017-03-06
Z-2551-2018	Class II	ImplantDirect, Dental implants intended for use in partially and fully edentulous upper...	Implant Direct Sybron Manufacturing LLC	DZE	2017-03-03
Z-0894-2018	Class II	LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0893-2018	Class II	LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0892-2018	Class II	LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0891-2018	Class II	LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0890-2018	Class II	LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0889-2018	Class II	LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0888-2018	Class II	LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0887-2018	Class II	LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0886-2018	Class II	LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0885-2018	Class II	LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0884-2018	Class II	LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0883-2018	Class II	LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0882-2018	Class II	LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0881-2018	Class II	LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx...	Bausch & Lomb Incorporated	HNN	2017-03-03
Z-0880-2018	Class II	LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG...	Bausch & Lomb Incorporated	HNN	2017-03-03