510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,476 records, page 947 of 1190
FDA device recalls, page 947 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2102-2009South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01, Integra...Integra Pain ManagementCAZ
Z-2101-2009Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra...Integra Pain ManagementCAZ
Z-2100-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01...Integra Pain ManagementCAZ
Z-2099-2009Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES...Integra Pain ManagementCAZ
Z-2098-2009CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder...Integra Pain ManagementCAZ
Z-2097-2009Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994, Integra...Integra Pain ManagementCAZ
Z-2096-2009Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651, Integra...Integra Pain ManagementCAZ
Z-2095-2009Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra...Integra Pain ManagementCAZ
Z-2094-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra...Integra Pain ManagementCAZ
Z-2093-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453, Integra...Integra Pain ManagementCAZ
Z-2092-2009Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01, Integra...Integra Pain ManagementCAZ
Z-2091-2009Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX)...Integra Pain ManagementCAZ
Z-2090-2009Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02, Integra...Integra Pain ManagementCAZ
Z-2089-2009Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189, Integra...Integra Pain ManagementCAZ
Z-2088-2009Block Tray, Disposable, Convenience Kit, Reorder Number CUS835, Integra LifeSciences...Integra Pain ManagementCAZ
Z-2087-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01...Integra Pain ManagementCAZ
Z-2086-2009Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02, Integra...Integra Pain ManagementCAZ
Z-2085-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra...Integra Pain ManagementCAZ
Z-2084-2009Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra...Integra Pain ManagementHBG
Z-2083-2009Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, Integra...Integra Pain ManagementCAZ
Z-2082-2009Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01, Integra...Integra Pain ManagementCAZ
Z-2081-2009Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234, Integra...Integra Pain ManagementCAZ
Z-2080-2009Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra...Integra Pain ManagementCAZ
Z-2079-2009Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra...Integra Pain ManagementCAZ
Z-1814-2009ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy...ConvaTec LimitedOMP
Z-2149-20114Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound...Siemens Medical Solutions USA, Inc.
Z-2234-2009S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W...Leonhard Lang GmbHMKJ
Z-2233-2009SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard...Leonhard Lang GmbHMKJ
Z-1988-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1987-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1986-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1985-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1984-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1983-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1982-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1981-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1980-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1979-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1978-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1977-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1976-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1975-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1974-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1973-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1972-2009Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code...Omni Life Science, Inc.KWY
Z-1971-2009Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD Product Code: H3-82243. Intended...Omni Life Science, Inc.KWY
Z-1970-2009Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD Product Code: H3-82242. Intended...Omni Life Science, Inc.KWY
Z-1969-2009Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended...Omni Life Science, Inc.KWY
Z-1968-2009Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD Product Code: H3-82240. Intended...Omni Life Science, Inc.KWY
Z-1967-2009Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD Product Code: H3-82239. Intended...Omni Life Science, Inc.KWY