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 741 of 1191

FDA device recalls, page 741 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2053-2013	Class II	SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	DJG	2013-07-29
Z-2052-2013	Class II	SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	DKZ	2013-07-29
Z-2051-2013	Class II	SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	DIO	2013-07-29
Z-2050-2013	Class II	SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	LDJ	2013-07-29
Z-2049-2013	Class II	SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	DKZ	2013-07-29
Z-2048-2013	Class II	SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY...	Sarken, Inc.	DIO	2013-07-29
Z-1616-2016	Class II	Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate...	Atlas Spine, Inc.	MQP	2013-07-26
Z-2261-2013	Class II	Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular...	Terumo Cardiovascular Systems Corporation	DTM	2013-07-26
Z-1896-2013	Class II	Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30...	Aso LLC	MGO	2013-07-26
Z-1895-2013	Class II	TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile...	Aso LLC	MGO	2013-07-26
Z-1894-2013	Class II	Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in...	Aso LLC	MGO	2013-07-26
Z-1893-2013	Class II	Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile...	Aso LLC	MGO	2013-07-26
Z-1892-2013	Class II	Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile...	Aso LLC	MGO	2013-07-26
Z-1891-2013	Class II	HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex...	Aso LLC	MGO	2013-07-26
Z-1890-2013	Class II	Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in...	Aso LLC	MGO	2013-07-26
Z-1889-2013	Class II	Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in...	Aso LLC	MGO	2013-07-26
Z-1888-2013	Class II	CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in...	Aso LLC	MGO	2013-07-26
Z-0090-2014	Class II	DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY...	Eastman Kodak Company	IZL	2013-07-26
Z-1978-2013	Class II	220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1977-2013	Class II	100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1974-2013	Class II	Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1973-2013	Class II	Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1969-2013	Class II	Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1968-2013	Class II	Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo...	Terumo Cardiovascular Systems Corporation	DTQ	2013-07-26
Z-1275-2014	Class II	DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product...	Varian Medical Systems, Inc.	LLZ	2013-07-25
Z-0973-2014	Class II	Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and...	Medtronic Navigation, Inc	OXO	2013-07-25
Z-2173-2013	Class II	KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080...	Roche Molecular Systems Inc	MAQ	2013-07-25
Z-2174-2013	Class II	STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low...	Advanced Sterilization Products	MLR	2013-07-25
Z-0101-2014	Class II	HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB...	HemoCue AB	GKR	2013-07-25
Z-2172-2013	Class II	ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro...	Siemens Healthcare Diagnostics Inc.	CGN	2013-07-25
Z-2171-2013	Class II	ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	CGN	2013-07-25
Z-2170-2013	Class II	ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use...	Siemens Healthcare Diagnostics Inc.	CGN	2013-07-25
Z-1992-2013	Class II	Stryker Visum 300 Ceiling-mounted Exam Light.	STRYKER Communications, Inc.	KZF	2013-07-25
Z-2169-2013	Class II	ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	CGN	2013-07-25
Z-0155-2014	Class III	ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to...	Hill-Rom Inc.	JEA	2013-07-24
Z-1941-2013	Class II	3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to...	Orthopediatrics Corp	HWC	2013-07-24
Z-1983-2013	Class II	GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile...	Gyrus ACMI, Inc.	GEI	2013-07-24
Z-1922-2013	Class II	Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10...	Novartis Nutrition Corp.	FPD	2013-07-24
Z-2267-2013	Class II	DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott...	Microgenics Corporation	DIO	2013-07-23
Z-0138-2014	Class II	Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device...	Elekta Limited	HAW	2013-07-23
Z-1171-2014	Class II	Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage...	ZimVie US Corp LLC	LRO	2013-07-22
Z-1170-2014	Class II	Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded...	ZimVie US Corp LLC	LRO	2013-07-22
Z-1169-2014	Class II	Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding...	ZimVie US Corp LLC	LRO	2013-07-22
Z-1168-2014	Class II	Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in...	ZimVie US Corp LLC	LRO	2013-07-22
Z-1167-2014	Class II	Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various...	ZimVie US Corp LLC	LRO	2013-07-22
Z-0390-2014	Class II	3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic...	Synthes GmbH	HWC	2013-07-22
Z-0019-2014	Class II	MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.	Philips North America LLC	JAK	2013-07-22
Z-2089-2013	Class II	Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage...	Mckesson Technologies, Inc.	BRY	2013-07-22
Z-2250-2013	Class II	ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer...	Instrumentation Laboratory Co.	GKP	2013-07-19
Z-2249-2013	Class II	ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated...	Instrumentation Laboratory Co.	GKP	2013-07-19