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-3140-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449... | Cook Incorporated | MIH | ||
| Z-3139-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444... | Cook Incorporated | MIH | ||
| Z-3138-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432... | Cook Incorporated | MIH | ||
| Z-3137-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428... | Cook Incorporated | MIH | ||
| Z-3136-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427... | Cook Incorporated | MIH | ||
| Z-3135-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422... | Cook Incorporated | MIH | ||
| Z-3134-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418... | Cook Incorporated | MIH | ||
| Z-3133-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF... | Cook Incorporated | MIH | ||
| Z-3132-2011 | Cook Medical, Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-96-ZT, REF... | Cook Incorporated | MIH | ||
| Z-3131-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408... | Cook Incorporated | MIH | ||
| Z-2383-2011 | Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile... | Gyrus ACMI, Inc. | KNY | ||
| Z-2404-2011 | ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator)... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-3130-2011 | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407... | Cook Incorporated | MIH | ||
| Z-0688-2012 | STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller... | ConMed Corporation | FPA | ||
| Z-0687-2012 | STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 60... | ConMed Corporation | FPA | ||
| Z-0686-2012 | STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller... | ConMed Corporation | FPA | ||
| Z-0685-2012 | STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 20... | ConMed Corporation | FPA | ||
| Z-0684-2012 | STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12... | ConMed Corporation | FPA | ||
| Z-0683-2012 | STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length... | ConMed Corporation | LDR | ||
| Z-0636-2012 | STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84... | ConMed Corporation | FPA | ||
| Z-0635-2012 | STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84 in. length... | ConMed Corporation | FPA | ||
| Z-0634-2012 | STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No... | ConMed Corporation | FPA | ||
| Z-0633-2012 | STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84... | ConMed Corporation | FPA | ||
| Z-0632-2012 | STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84 in. length... | ConMed Corporation | FPA | ||
| Z-0631-2012 | STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 in. length, Catalog/REF... | ConMed Corporation | FPA | ||
| Z-0630-2012 | STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12... | ConMed Corporation | FPA | ||
| Z-0682-2012 | STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO... | ConMed Corporation | LDR | ||
| Z-0629-2012 | STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525... | ConMed Corporation | LDR | ||
| Z-2860-2011 | I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent... | Halyard Health | MEB | ||
| Z-3127-2011 | UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-3126-2011 | Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2238-2011 | Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit... | Maquet Cardiovascular Us Sales, LLC | KXJ | ||
| Z-2457-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2456-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2455-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2454-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2453-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2452-2011 | Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2451-2011 | Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2450-2011 | Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2449-2011 | Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2448-2011 | Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2447-2011 | Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2446-2011 | Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2445-2011 | Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2444-2011 | Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2443-2011 | Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2442-2011 | Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2441-2011 | Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2440-2011 | Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use... | Zimmer GmbH | KWA |