Medical Device
Manufacturing
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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

59,486 records, page 870 of 1190
FDA device recalls, page 870 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3104-2011Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue...Express Diagnostics Int'l., Inc.DIC
Z-0626-2011ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System...Medtronic, Inc.FGE
Z-0824-2011Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog...Zimmer GmbHHSB
Z-1361-2011EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code)...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1360-2011ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1359-2011RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code)...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1358-2011ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1357-2011QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code)...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1356-2011RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1355-2011ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1354-2011NERVE BLOCK PREP TRAY/Product SKU (Code) ASK-04001-VCU. Nerve block prep tray for...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1353-2011PREP TRAY/Product SKU (Code) ASK-04001-SLE. Prep tray for epidural anesthesia kitArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1352-2011EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1351-2011ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1350-2011EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) EPIDURAL CATHETER -- Product SKU (Code)...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1349-2011JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kitArrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1348-2011CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1347-2011VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1346-2011ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kitArrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1345-2011PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1344-2011INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code)...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-1343-2011SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-0587-2011Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid...Baxter Healthcare CorporationFMG
Z-0714-2011CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy...Accuray IncorporatedIYE
Z-0465-2011Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open...C.R. Bard IncKNT
Z-0586-2011Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile...Baxter Healthcare CorporationFMG
Z-1596-2011Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser...Abbott MedicalFRN
Z-2569-2011Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used...Elekta LimitedMUJ
Z-0946-2011GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with...GE HealthcareJAK
Z-1318-201102.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1317-201102.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1316-201102.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1315-201102.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1314-201102.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1313-201102.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1312-201102.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1311-201102.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1310-201102.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1309-201102.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1308-201102.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1307-201102.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1306-201102.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1305-201102.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1304-201102.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1303-201102.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1302-201102.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1301-201102.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-300-201102.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW
Z-1299-201102.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the...Synthes GmbHKTW
Z-1298-201102.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of...Synthes GmbHKTW