Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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 , the FDA export date. FDA medical device recall database

59,486 records, page 756 of 1190
FDA device recalls, page 756 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1360-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1359-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1341-2013Class IIRostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050...MEDLINE INDUSTRIES, LP - NorthfieldOTO
Z-1358-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1357-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1356-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1355-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic...Progressive Medical IncGEI
Z-1354-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1353-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1352-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1351-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1350-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic...Progressive Medical IncGEI
Z-1349-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1348-2013Class IIProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY...Progressive Medical IncGEI
Z-1304-2013Class IIICurity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.Medtronic, Inc.KDD
Z-1303-2013Class IIICurity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV...Medtronic, Inc.LRS
Z-0522-2014Class IIKayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITALmobility unlimited Inc dba kayserbetten USFNL
Z-0613-2014Class IIPhilips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC...Philips North America LLCMKJ
Z-1967-2013Class IIThe Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a...GE HealthcareKPS
Z-1339-2013Class IILATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient...Boston Scientific CorporationLWS
Z-1267-2013Class IICodman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide...Symmetry Surgical GmbHDWS
Z-2266-2013Class IIGE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model...GE HealthcareLNH
Z-1778-2013Class IIIDermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a...National Biological Corp.FTC
Z-1784-2013Class IIHemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for...Instrumentation Laboratory Co.GJS
Z-0795-2014Class IIOxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in...Remel IncJTN
Z-0794-2014Class IIOxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in...Remel IncJTN
Z-0793-2014Class IIOxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in...Remel IncJTN
Z-0792-2014Class IIOxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in...Remel IncJTN
Z-1407-2013Class IINatus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502...Alpine Biomed ApSGWF
Z-2292-2013Class IISolitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral...Ebi, LLCMAX
Z-1772-2013Class IIEndopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks...Ethicon Endo-Surgery IncGCJ
Z-1779-2013Class IIIDermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a...National Biological Corp.FTC
Z-1185-2013Class IIMedi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID...Medtronic, Inc.DRO
Z-1184-2013Class IIMedi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID...Medtronic, Inc.DRO
Z-1189-2013Class IIHeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC...Philips North America LLCMKJ
Z-1171-2013Class INewport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model...Newport Medical Instruments, Inc.CBK
Z-1329-2013Class IIPROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of...MEDTOX Diagnostics, Inc.DIO
Z-0700-2016Class IIBiosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic...Smith & Nephew, Inc.NBH
Z-0699-2016Class IIBiosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws...Smith & Nephew, Inc.HWR
Z-0530-2014Class IIremel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of...Remel IncJXB
Z-0425-2014Class II13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers...B Braun Medical IncLHI
Z-0424-2014Class II20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers...B Braun Medical IncLHI
Z-1403-2013Class IIPTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage...Polymer Technology SystemsNBW
Z-1375-2013Class IIQuietCare. Intended for use in monitoring the environmental conditions and activity...Intel-Ge Care Innovations, LLCIQA
Z-1374-2013Class IIQuietCare-Networked. Intended for use in monitoring the environmental conditions and...Intel-Ge Care Innovations, LLCIQA
Z-1276-2013Class IIExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of...Medshape, Inc.MBI
Z-1446-2013Class IILPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846...Leica Microsystems, Inc.IDZ
Z-1182-2013Class IISoftware correction applies to customers who use the RT Therapist RTT4.2.108 and RT...Siemens Medical Solutions USA, Inc.IYE
Z-1368-2013Class IICobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the...Roche Diagnostics GmbHJJE
Z-2117-2013Class IIGE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM...GE HealthcareMHX