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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 766 of 1190

FDA device recalls, page 766 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0930-2013	Class II	ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed...	Siemens Medical Solutions USA, Inc.	IYO	2013-01-18
Z-0885-2013	Class II	Elekta, Apex add-on Micro MLC, collimator for radiation therapy.	Elekta Limited	IXI	2013-01-18
Z-0763-2013	Class I	St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model...	Abbott Medical	DQY	2013-01-18
Z-0809-2013	Class II	Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab...	GUNNELL, Inc.	IOR	2013-01-18
Z-1545-2013	Class II	SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo...	Ormco/Sybronendo	EKR	2013-01-17
Z-1544-2013	Class II	SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332...	Ormco/Sybronendo	EKR	2013-01-17
Z-0907-2013	Class II	SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No...	Siemens Medical Solutions USA, Inc.	IYE	2013-01-17
Z-0744-2013	Class III	KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number...	Eastman Kodak Company	IWZ	2013-01-17
Z-0866-2013	Class II	Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and...	Merit Medical Systems, Inc.	FGE	2013-01-16
Z-1448-2013	Class II	Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052...	Philips North America LLC	MQB	2013-01-16
Z-1447-2013	Class II	Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052...	Philips North America LLC	MQB	2013-01-16
Z-0751-2013	Class II	45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model...	Greatbatch Medical	LXH	2013-01-16
Z-1450-2013	Class II	Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035...	Philips North America LLC	KPR	2013-01-16
Z-1449-2013	Class II	Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers...	Philips North America LLC	KPR	2013-01-16
Z-0767-2013	Class II	Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal...	Philips North America LLC	KPR	2013-01-16
Z-1097-2013	Class II	Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic...	Siemens Medical Solutions USA, Inc.	JAA	2013-01-15
Z-0968-2013	Class I	Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and...	GE Healthcare	CBK	2013-01-15
Z-0963-2013	Class II	DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of...	DePuy Spine, Inc.	NDN	2013-01-15
Z-0962-2013	Class II	DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery...	DePuy Spine, Inc.	NDN	2013-01-15
Z-0961-2013	Class II	DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of...	DePuy Spine, Inc.	NDN	2013-01-15
Z-0960-2013	Class II	DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of...	DePuy Spine, Inc.	NDN	2013-01-15
Z-1519-2013	Class II	GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital...	GE Healthcare	MUE	2013-01-14
Z-0912-2013	Class II	Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac...	AtriCure, Inc.	OCL	2013-01-14
Z-0838-2013	Class II	LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare...	Ansell Healthcare Products LLC	HIS	2013-01-14
Z-0804-2013	Class II	BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510...	Breg Inc	ILO	2013-01-14
Z-0803-2013	Class II	BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U...	Breg Inc	ILO	2013-01-14
Z-0766-2013	Class II	P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii...	Tobii Assistive Technology, Inc.	ILQ	2013-01-14
Z-0824-2013	Class II	Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279...	Philips North America LLC	DXN	2013-01-14
Z-0768-2013	Class II	Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also...	Oxus America, Inc.	CAW	2013-01-14
Z-1866-2013	Class II	Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1865-2013	Class II	Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1864-2013	Class II	Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1863-2013	Class II	Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1862-2013	Class II	Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1861-2013	Class II	Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-1860-2013	Class II	Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of...	Acclarent Inc	KTI	2013-01-11
Z-0905-2013	Class II	Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number...	Synthes GmbH	DZL	2013-01-11
Z-0904-2013	Class II	Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number...	Synthes GmbH	DZL	2013-01-11
Z-0941-2013	Class II	Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product...	Synthes GmbH	KTT	2013-01-11
Z-0938-2013	Class II	Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part...	Synthes GmbH	MNH	2013-01-11
Z-0942-2013	Class II	Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary...	Synthes GmbH	JEY	2013-01-11
Z-1016-2013	Class II	Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the...	Synthes GmbH	HWC	2013-01-11
Z-2282-2013	Class II	Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The...	Synthes GmbH	LXH	2013-01-11
Z-1062-2013	Class II	Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the...	Synthes GmbH	LXH	2013-01-11
Z-0956-2013	Class II	Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number...	Synthes GmbH	HRS	2013-01-11
Z-0903-2013	Class II	Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone...	Synthes GmbH	DZL	2013-01-11
Z-0865-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0864-2013	Class II	NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0863-2013	Class II	NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11
Z-0862-2013	Class II	NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the...	Cerenovus, Inc.	DQY	2013-01-11