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

59,486 records, page 758 of 1190
FDA device recalls, page 758 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1282-2013Class IIDural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of...Integra LifeSciences CorporationGXQ
Z-1147-2013Class IIHCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit...Transonic Systems IncDXG
Z-1158-2013Class IIBelly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection...Teleflex MedicalKNX
Z-1243-2013Class IIWallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with...Abbott MedicalMQF
Z-1242-2013Class IIWallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro...Abbott MedicalMQF
Z-1241-2013Class IIWallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product...Abbott MedicalMQF
Z-1240-2013Class IIWallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code...Abbott MedicalMQF
Z-1239-2013Class IIWallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product...Abbott MedicalMQF
Z-1271-2013Class IIA) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2...Baxter Healthcare CorporationFPA
Z-1270-2013Class IIA) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes...Baxter Healthcare CorporationFPA
Z-1269-2013Class IIA) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2...Baxter Healthcare CorporationFPA
Z-1268-2013Class IIA) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male...Baxter Healthcare CorporationFPA
Z-1376-2013Class IINEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare...Zimmer GmbHHTW
Z-1319-2013Class IISummit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical...Summit Medical, LLCJYO
Z-1155-2013Class IIRoboCouch Patient Positioning System Product Usage: is intended for use in the support...Accuray IncorporatedJAI
Z-1237-2013Class IIStryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal...Stryker Corp.GCX
Z-1236-2013Class IIStryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction...Stryker Corp.GCX
Z-1235-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective...Stryker Corp.GCX
Z-1234-2013Class IIStryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward...Stryker Corp.GCX
Z-1233-2013Class IIStryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective...Stryker Corp.GCX
Z-1232-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective...Stryker Corp.GCX
Z-1231-2013Class IIStryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective...Stryker Corp.GCX
Z-1230-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective...Stryker Corp.GCX
Z-1229-2013Class IIStryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective...Stryker Corp.GCX
Z-1228-2013Class IIStryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal...Stryker Corp.GCX
Z-1227-2013Class IIStryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal...Stryker Corp.GCX
Z-1226-2013Class IIStryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal...Stryker Corp.GCX
Z-1225-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator...Stryker Corp.GCX
Z-1224-2013Class IIStryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction...Stryker Corp.GCX
Z-1223-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal...Stryker Corp.GCX
Z-1222-2013Class IIStryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction...Stryker Corp.GCX
Z-1221-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal...Stryker Corp.GCX
Z-1220-2013Class IIStryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction...Stryker Corp.GCX
Z-1219-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction...Stryker Corp.GCX
Z-1218-2013Class IIStryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction...Stryker Corp.GCX
Z-0024-2014Class IIGE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation...GE HealthcareKPS
Z-0023-2014Class IIGE, Optima CT660. Intended to produce cross-sectional images of the body by computer...GE HealthcareJAK
Z-1192-2013Class IIMediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item...Owens & Minor Distribution, Inc.KXF
Z-1163-2013Class IIVarian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model...Varian Medical Systems, Inc.IYE
Z-1135-2013Class IIEdwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the...Edwards Lifesciences LLCNPT
Z-1206-2013Class IPresource PBDS, Knee Arthroscopy, Kit, CirculatorMedtronic, Inc.OFP
Z-1134-2013Class IIEdwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the...Edwards Lifesciences LLCNPT
Z-1205-2013Class IPresource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, KitMedtronic, Inc.OFP
Z-1204-2013Class IPresource PBDS, Total Knee, Kit, CirculatorMedtronic, Inc.OFP
Z-1203-2013Class IPresource PBDS, Total Joint, Kit, CirculatorMedtronic, Inc.OFP
Z-1202-2013Class IPresource PBDS, Total Hip, Kit, CirculatorMedtronic, Inc.OFP
Z-1201-2013Class IPresource PBDS, Shoulder Procedure, Kit, CirculatorMedtronic, Inc.OFP
Z-1200-2013Class IPresource PBDS, Shoulder Arthroscopy, Kit, CirculatorMedtronic, Inc.OFP
Z-1199-2013Class IPresource PBDS, Hand, Kit, CirculatorMedtronic, Inc.OFP
Z-1198-2013Class IPresource PBDS, Extremity, Kit, CirculatorMedtronic, Inc.OFP