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 750 of 1191

FDA device recalls, page 750 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2002-2013	Class II	00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR...	Zimmer GmbH	JWH	2013-06-07
Z-2001-2013	Class II	65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR...	Zimmer GmbH	JWH	2013-06-07
Z-2000-2013	Class II	00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS...	Zimmer GmbH	JWH	2013-06-07
Z-1999-2013	Class II	00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx...	Zimmer GmbH	JWH	2013-06-07
Z-1998-2013	Class II	00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx...	Zimmer GmbH	JWH	2013-06-07
Z-1600-2013	Class II	Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the...	Baxter Healthcare Corporation	MEB	2013-06-07
Z-1609-2013	Class II	Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's...	Baxter Healthcare Corporation	MEB	2013-06-07
Z-2195-2013	Class II	AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal...	Sybron Dental Specialties, Inc.	DYJ	2013-06-06
Z-1982-2013	Class II	EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001...	Endogastric Solutions, Inc.	ODE	2013-06-06
Z-1805-2013	Class II	BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged...	Becton Dickinson & Co	JSI	2013-06-06
Z-1804-2013	Class II	BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates...	Becton Dickinson & Co	JSI	2013-06-06
Z-1803-2013	Class II	BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840...	Becton Dickinson & Co	JSI	2013-06-06
Z-1802-2013	Class II	BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100...	Becton Dickinson & Co	JSI	2013-06-06
Z-1801-2013	Class II	BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar...	Becton Dickinson & Co	JSJ	2013-06-06
Z-1800-2013	Class II	BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in...	Becton Dickinson & Co	JSJ	2013-06-06
Z-1799-2013	Class II	BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555...	Becton Dickinson & Co	JSJ	2013-06-06
Z-1798-2013	Class II	BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part...	Becton Dickinson & Co	JWY	2013-06-06
Z-1948-2013	Class II	Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-06-06
Z-0126-2014	Class II	Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.	Eastman Kodak Company	IZL	2013-06-06
Z-0599-2020	Class II	PANTERA Proximal Humerus Fracture Plate System	Toby Orthopaedics	HRS	2013-06-05
Z-0428-2014	Class III	3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are...	3M Company	ELZ	2013-06-05
Z-1955-2013	Class II	Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100...	Fisher Scientific Company L.L.C.	KXG	2013-06-05
Z-1795-2013	Class II	Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device...	Siemens Medical Solutions USA, Inc.	MQB	2013-06-05
Z-1935-2013	Class II	5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm...	Synthes GmbH	MNI	2013-06-05
Z-1925-2013	Class II	Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase...	Siemens Healthcare Diagnostics Inc.	JIT	2013-06-05
Z-0603-2014	Class II	Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure...	Terumo Cardiovascular Systems Corporation	MNJ	2013-06-04
Z-1868-2013	Class II	Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in...	Mesa Laboratories Inc	FRC	2013-06-04
Z-1867-2013	Class II	Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the...	Mesa Laboratories Inc	FRC	2013-06-04
Z-1537-2013	Class I	Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N)...	Respironics, Inc.	MNT	2013-06-04
Z-1543-2013	Class II	Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable...	Utah Medical Products, Inc	DRS	2013-06-04
Z-2270-2013	Class II	Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a...	Invacare GmbH	ITI	2013-06-04
Z-1752-2013	Class II	ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds...	Baxter Corporation Englewood	LHI	2013-06-04
Z-0653-2014	Class II	Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug...	Alere San Diego, Inc.	DKZ	2013-06-03
Z-1580-2013	Class I	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1579-2013	Class I	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1834-2013	Class II	AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software...	Siemens Healthcare Diagnostics Inc.	JJE	2013-06-03
Z-1571-2013	Class I	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1576-2013	Class I	Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1575-2013	Class I	Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1574-2013	Class I	Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1877-2013	Class II	Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a...	Eastman Kodak Company	KPR	2013-06-03
Z-1568-2013	Class III	CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end...	Integra LifeSciences Corporation	KYI	2013-06-03
Z-1573-2013	Class I	Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1674-2013	Class II	Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated...	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2013-06-03
Z-1570-2013	Class I	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40...	Medtronic Neuromodulation	LKK	2013-06-03
Z-1745-2013	Class II	Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part...	Synthes GmbH	DZL	2013-05-31
Z-2057-2013	Class II	Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment...	Synthes (USA) Products LLC	HRS	2013-05-31
Z-1728-2013	Class II	27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter...	Karl Storz Endoscopy-America, Inc.	GBA	2013-05-31
Z-1608-2013	Class II	Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit...	Greatbatch Medical	DYB	2013-05-31
Z-1662-2013	Class III	BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in...	Becton Dickinson & Co	NJR	2013-05-31