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