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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 356 of 1190
FDA device recalls, page 356 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1198-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1197-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1196-2020Class IIFlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1195-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BOArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1194-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPIArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1193-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code CA-02220Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1192-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHHArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1191-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXLArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1190-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHOArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1189-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHHArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1188-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTELArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1187-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LINArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1186-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEOArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1185-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSCArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1184-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WHArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1183-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1182-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BIDArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1181-2020Class IIEpidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1180-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SHArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1179-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1178-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BIDArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1177-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code AK-05500Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1176-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TMArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1175-2020Class IITheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1174-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRHArrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1173-2020Class IIEPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-BArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1172-2020Class IIFlexTip Plus Epidural Catheterization Kit, Product Code AK-05501Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-1171-2020Class IIFlexTip Plus Epidural Catheterization Set, Product Code AA-05400-EArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-1263-2020Class IIi-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage...Abbott MedicalKHP
Z-1262-2020Class IIi-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product...Abbott MedicalJGS
Z-1170-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-BArrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-2286-2020Class IIOrmco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13...Ormco/SybronendoEJF
Z-1886-2020Class IIBodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm)...CME America, LLCFPA
Z-1450-2020Class IIMedtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral...Medtronic Heart Valves DivisionDTI
Z-1449-2020Class IIMedtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a...Medtronic Heart Valves DivisionDTI
Z-1342-2020Class IIAmbulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart...Philips North America LLCMKJ
Z-1265-2020Class IIi-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage...Abbott MedicalCHL
Z-1345-2020Class IIPhilips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT...Philips North America LLCMWJ
Z-1330-2020Class IIDP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product...Datascope Corp.IYN
Z-1219-2020Class IIThe Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for...C.R. Bard IncPHU
Z-1228-2020Class IICoopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic)...CooperVision, Inc.LPM
Z-1227-2020Class IICoopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic)...CooperVision, Inc.LPM
Z-1270-2020Class IITeleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF...Teleflex MedicalDWS
Z-1269-2020Class IIPilling Aortic Punch, 4.0 mm Standard Tip, REF 353440Teleflex MedicalDWS
Z-1099-2020Class IITelescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil...Stryker Corp.GEI
Z-1098-2020Class IITelescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie...Stryker Corp.GEI
Z-1097-2020Class IISafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a...Stryker Corp.GEI
Z-1421-2020Class IIAtellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143Siemens Healthcare Diagnostics Inc.JGS
Z-1040-2020Class IIAAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511Medtronic, Inc.FYA
Z-1039-2020Class IIAAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585Medtronic, Inc.FYA