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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 719 of 1191

FDA device recalls, page 719 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0938-2014	Class II	Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial...	Integra LifeSciences Corporation	NKB	2014-01-22
Z-0925-2014	Class II	SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are...	CareFusion 303, Inc	FPA	2014-01-22
Z-1235-2014	Class II	Buzzaround XL scooters' Product Usage: mobility	Golden Technologies, Inc	INI	2014-01-21
Z-1093-2014	Class II	Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product...	Agilent Technologies, Inc.	NYQ	2014-01-21
Z-1078-2014	Class II	GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography...	GE Healthcare	MQB	2014-01-20
Z-0918-2014	Class II	Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN...	Edwards Lifesciences LLC	NPT	2014-01-20
Z-1146-2014	Class II	ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and...	Horiba Instruments Incorporated	JIX	2014-01-20
Z-1124-2014	Class II	MEDITECH Microbiology - Calculator/data processing module, for clinical use.	Medical Information Technology, Inc.	JQP	2014-01-17
Z-1134-2014	Class II	DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE...	DeRoyal Industries, Inc.	HFX	2014-01-16
Z-0931-2014	Class II	Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP...	CareFusion 303, Inc	FPA	2014-01-16
Z-0935-2014	Class II	LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal...	Zest Anchors LLC	DZE	2014-01-16
Z-1193-2014	Class III	VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684...	Ortho-Clinical Diagnostics, Inc.	JIT	2014-01-15
Z-1091-2014	Class II	The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching...	Palodex Group Oy	EHD	2014-01-14
Z-0845-2014	Class II	InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product...	Philips North America LLC	NCX	2014-01-13
Z-0828-2014	Class II	Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale...	Accuray Incorporated	IYE	2014-01-13
Z-1710-2014	Class II	Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant...	Leica Microsystems, Inc.	NJT	2014-01-10
Z-0846-2014	Class II	Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu...	DiaSorin Molecular LLC	OCC	2014-01-10
Z-0827-2014	Class I	T:slim Insulin Delivery System Insulin Infusion Pump	Tandem Diabetes Care, Inc.	LZG	2014-01-10
Z-1092-2014	Class II	00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48...	Zimmer GmbH	KWT	2014-01-10
Z-1162-2014	Class II	Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1161-2014	Class II	Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1160-2014	Class II	Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1159-2014	Class II	Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1158-2014	Class II	Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1157-2014	Class II	Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are...	Smith & Nephew, Inc.	OMP	2014-01-09
Z-1132-2014	Class II	Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used...	Mako Surgical Corp.	NPJ	2014-01-09
Z-1226-2014	Class II	VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT...	Ortho-Clinical Diagnostics, Inc.	CIG	2014-01-09
Z-0908-2014	Class II	Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used...	Medtronic Heart Valves Division	LWR	2014-01-09
Z-1679-2014	Class II	115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a...	Gentherm Medical, LLC	DWJ	2014-01-08
Z-1574-2014	Class II	ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG...	The Anspach Effort, Inc.	HTT	2014-01-08
Z-1156-2014	Class II	Panaroma Central Station Product Usage: This device can view real time, store, print...	Datascope Corp.	MHX	2014-01-08
Z-1195-2014	Class II	CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is...	Veridex, LLC	NQI	2014-01-08
Z-0934-2014	Class II	3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No...	Orthopediatrics Corp	HWC	2014-01-08
Z-0919-2014	Class II	Impax Ris Qdoc 5.8	AGFA Healthcare Corp.	LLZ	2014-01-08
Z-0987-2014	Class II	SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device...	B Braun Medical Inc	FPA	2014-01-08
Z-1274-2014	Class II	Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of...	Synthes GmbH	HRS	2014-01-07
Z-1057-2014	Class II	Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN...	Synthes GmbH	LXH	2014-01-07
Z-0813-2014	Class II	AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular...	Vygon Mfg	FPA	2014-01-07
Z-1313-2014	Class II	Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey"...	Infantino LLC	MEF	2014-01-06
Z-1217-2014	Class II	Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine...	Exactech, Inc.	MNI	2014-01-06
Z-1111-2014	Class II	cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media...	Roche Molecular Systems Inc	OOI	2014-01-06
Z-0900-2014	Class II	Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using...	Boston Scientific Corporation	ITX	2014-01-06
Z-0977-2014	Class II	Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA...	Medtronic Sofamor Danek USA Inc	MBP	2014-01-06
Z-0963-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0962-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0961-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0960-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0959-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0958-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06
Z-0957-2014	Class I	ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded...	Teleflex Medical	BTR	2014-01-06