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-1282-2013 | Class II | Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of... | Integra LifeSciences Corporation | GXQ | |
| Z-1147-2013 | Class II | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit... | Transonic Systems Inc | DXG | |
| Z-1158-2013 | Class II | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection... | Teleflex Medical | KNX | |
| Z-1243-2013 | Class II | Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with... | Abbott Medical | MQF | |
| Z-1242-2013 | Class II | Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro... | Abbott Medical | MQF | |
| Z-1241-2013 | Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product... | Abbott Medical | MQF | |
| Z-1240-2013 | Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code... | Abbott Medical | MQF | |
| Z-1239-2013 | Class II | Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product... | Abbott Medical | MQF | |
| Z-1271-2013 | Class II | A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2... | Baxter Healthcare Corporation | FPA | |
| Z-1270-2013 | Class II | A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes... | Baxter Healthcare Corporation | FPA | |
| Z-1269-2013 | Class II | A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2... | Baxter Healthcare Corporation | FPA | |
| Z-1268-2013 | Class II | A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male... | Baxter Healthcare Corporation | FPA | |
| Z-1376-2013 | Class II | NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare... | Zimmer GmbH | HTW | |
| Z-1319-2013 | Class II | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical... | Summit Medical, LLC | JYO | |
| Z-1155-2013 | Class II | RoboCouch Patient Positioning System Product Usage: is intended for use in the support... | Accuray Incorporated | JAI | |
| Z-1237-2013 | Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal... | Stryker Corp. | GCX | |
| Z-1236-2013 | Class II | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-1235-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1234-2013 | Class II | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward... | Stryker Corp. | GCX | |
| Z-1233-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1232-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1231-2013 | Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1230-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1229-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective... | Stryker Corp. | GCX | |
| Z-1228-2013 | Class II | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal... | Stryker Corp. | GCX | |
| Z-1227-2013 | Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal... | Stryker Corp. | GCX | |
| Z-1226-2013 | Class II | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal... | Stryker Corp. | GCX | |
| Z-1225-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator... | Stryker Corp. | GCX | |
| Z-1224-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-1223-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal... | Stryker Corp. | GCX | |
| Z-1222-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-1221-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal... | Stryker Corp. | GCX | |
| Z-1220-2013 | Class II | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-1219-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-1218-2013 | Class II | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction... | Stryker Corp. | GCX | |
| Z-0024-2014 | Class II | GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation... | GE Healthcare | KPS | |
| Z-0023-2014 | Class II | GE, Optima CT660. Intended to produce cross-sectional images of the body by computer... | GE Healthcare | JAK | |
| Z-1192-2013 | Class II | MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item... | Owens & Minor Distribution, Inc. | KXF | |
| Z-1163-2013 | Class II | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model... | Varian Medical Systems, Inc. | IYE | |
| Z-1135-2013 | Class II | Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the... | Edwards Lifesciences LLC | NPT | |
| Z-1206-2013 | Class I | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1134-2013 | Class II | Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the... | Edwards Lifesciences LLC | NPT | |
| Z-1205-2013 | Class I | Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit | Medtronic, Inc. | OFP | |
| Z-1204-2013 | Class I | Presource PBDS, Total Knee, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1203-2013 | Class I | Presource PBDS, Total Joint, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1202-2013 | Class I | Presource PBDS, Total Hip, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1201-2013 | Class I | Presource PBDS, Shoulder Procedure, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1200-2013 | Class I | Presource PBDS, Shoulder Arthroscopy, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1199-2013 | Class I | Presource PBDS, Hand, Kit, Circulator | Medtronic, Inc. | OFP | |
| Z-1198-2013 | Class I | Presource PBDS, Extremity, Kit, Circulator | Medtronic, Inc. | OFP |
