Medical Device
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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

59,460 records, page 1130 of 1190
FDA device recalls, page 1130 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0471-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0470-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0469-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0468-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0467-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0466-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0465-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0538-05Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.Siemens Healthcare Diagnostics Inc.DAP
Z-0464-05Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505...Abbott MedicalFPA
Z-0339-05ACT diff 2 Analyzer (Automated differential cell counter)Siemens Healthcare Diagnostics Inc.GKZ
Z-0383-05Roche brand Cardiac Reader.Roche Diagnostics GmbH
Z-0686-05CryoValve, Aortic Valve and ConduitArtivion, Inc.MIE
Z-0293-05Drger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, manufactured...Unomedical A/SBZA
Z-0292-05Unomedical REF 962MM, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen...Unomedical A/SBZA
Z-0291-05Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by...Unomedical A/SBZA
Z-0290-05Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult, manufactured by...Unomedical A/SBZA
Z-0289-05Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured...Unomedical A/SBZA
Z-0288-05Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated...Unomedical A/SBZA
Z-0287-05Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve...Unomedical A/SBZA
Z-0275-05Hospitak, REF 8026, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas...Unomedical A/SBZA
Z-0286-05Hospitak, REF 1450, Face Ten Mask w/ Aerosol Tubing 60'', Oxygen Tubing 7'' & Connector...Unomedical A/SBZA
Z-0285-05Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen...Unomedical A/SBZA
Z-0284-05Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12''...Unomedical A/SBZA
Z-0283-05Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12''...Unomedical A/SBZA
Z-0282-05Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10''...Unomedical A/SBZA
Z-0281-05Hospitak, REF 1011, IPPB Ventilator Circuit, manufactured by Unomedical, Inc of McAllen...Unomedical A/SBZA
Z-0280-05Hospitak, REF 903-E, IPPB Ventilator Circuit, manufactured by Unomedical, Inc of McAllen...Unomedical A/SBZA
Z-0368-05McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single...Cypress Medical Products LLCFQM
Z-0279-05Hospitak, REF 903-GM, IPPB Circuit Exhalation Valve & Nebulizer Circuit Universal 4''...Unomedical A/SBZA
Z-0299-05Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter...Baxter Healthcare Renal DivKDI
Z-0370-05Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.Philips North America LLCKPR
Z-0369-05Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811Philips North America LLCKPR
Z-0074-2011Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400...SCC Soft ComputerLNX
Z-1155-2007ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment...Northwest Medical Physics Equipment, Inc.IYE
Z-0417-05Video cart shelf system for organizing with three styles: standard, multispecialty, and...Stryker Corp.GCJ
Z-0346-05Hill-Rom CareAssist Bed; model P1170.Hill-Rom Inc.FNL
Z-0349-05NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-0366-05AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is...Abbott MedicalGBK
Z-0365-05AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is...Abbott MedicalGBK
Z-0364-05AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is...Abbott MedicalGBK
Z-0363-05AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled...Abbott MedicalGBK
Z-0362-05AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is...Abbott MedicalGBK
Z-0361-05AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is...Abbott MedicalGBK
Z-0360-05AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is...Abbott MedicalGBK
Z-0359-05AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is...Abbott MedicalGBK
Z-0358-05AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is...Abbott MedicalGBK
Z-0357-05AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled...Abbott MedicalGBK
Z-0356-05AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled...Abbott MedicalBGK
Z-0355-05AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled...Abbott MedicalGBK
Z-0354-05AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled...Abbott MedicalGBK