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-1621-2020 | Class II | Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115... | Stryker Corp. | NRY | |
| Z-1620-2020 | Class II | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115... | Stryker Corp. | NRY | |
| Z-0284-2020 | Class II | MaxZero Extension Sets with Needle-less Connector, Product codes... | Becton Dickinson & Co | FPA | |
| Z-1552-2020 | Class II | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x... | Quidel Cardiovascular Inc. | DIF | |
| Z-1731-2019 | Class II | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI... | Microbiologics, Inc. | PMN | |
| Z-1730-2019 | Class II | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product... | Microbiologics, Inc. | PMN | |
| Z-1342-2019 | Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1341-2019 | Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1340-2019 | Class II | Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1339-2019 | Class II | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-1725-2019 | Class II | Thoracentesis Set, RPN C-THS-850, Order # G03286 | Cook Incorporated | PYC | |
| Z-1724-2019 | Class II | Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 | Cook Incorporated | PYC | |
| Z-1723-2019 | Class II | Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 | Cook Incorporated | PYC | |
| Z-1722-2019 | Class II | Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 | Cook Incorporated | PYC | |
| Z-1363-2019 | Class III | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is... | Abbott Medical | JJY | |
| Z-1362-2019 | Class III | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is... | Abbott Medical | JJY | |
| Z-1361-2019 | Class III | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are... | Abbott Medical | JIT | |
| Z-1360-2019 | Class III | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT... | Abbott Medical | JIT | |
| Z-1359-2019 | Class III | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT... | Abbott Medical | JIT | |
| Z-1358-2019 | Class III | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators... | Abbott Medical | JIT | |
| Z-1357-2019 | Class III | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are... | Abbott Medical | JJX | |
| Z-1356-2019 | Class III | ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the... | Abbott Medical | JIT | |
| Z-1355-2019 | Class III | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are... | Abbott Medical | JIT | |
| Z-1936-2019 | Class II | VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1935-2019 | Class II | VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI #... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1934-2019 | Class II | VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1933-2019 | Class II | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1399-2019 | Class II | AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007... | Boston Scientific Corporation | GEX | |
| Z-1398-2019 | Class II | AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007... | Boston Scientific Corporation | GEX | |
| Z-1397-2019 | Class II | AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser... | Boston Scientific Corporation | GEX | |
| Z-1396-2019 | Class II | AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007... | Boston Scientific Corporation | GEX | |
| Z-1395-2019 | Class II | AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System... | Boston Scientific Corporation | GEX | |
| Z-1394-2019 | Class II | AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL... | Boston Scientific Corporation | GEX | |
| Z-1393-2019 | Class II | AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL... | Boston Scientific Corporation | GEX | |
| Z-1392-2019 | Class II | AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007... | Boston Scientific Corporation | GEX | |
| Z-1391-2019 | Class II | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007... | Boston Scientific Corporation | GEX | |
| Z-1488-2019 | Class II | CBS high, countersink, cannulated, AO, Item Number ST503004542 | Zimmer GmbH | HWW | |
| Z-1487-2019 | Class II | CBS micro, countersink, cannulated, AO, Item Number ST503004541 | Zimmer GmbH | HWW | |
| Z-1486-2019 | Class II | Drill, contra-angle, 1.5x85mm, Item Number ST502015706 | Zimmer GmbH | HTW | |
| Z-1485-2019 | Class II | Drill, 3.2x145mm, AO, Item Number ST502015650 | Zimmer GmbH | HTW | |
| Z-1484-2019 | Class II | Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640 | Zimmer GmbH | HTW | |
| Z-1483-2019 | Class II | Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635 | Zimmer GmbH | HTW | |
| Z-1482-2019 | Class II | Drill, cannulated, 3x90mm, AO, Item Number ST502015631 | Zimmer GmbH | HTW | |
| Z-1481-2019 | Class II | Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630 | Zimmer GmbH | HTW | |
| Z-1480-2019 | Class II | Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628 | Zimmer GmbH | HTW | |
| Z-1479-2019 | Class II | Drill, cannulated, 2x95mm, AO, Item Number ST502015623 | Zimmer GmbH | HTW | |
| Z-1478-2019 | Class II | Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621 | Zimmer GmbH | HTW | |
| Z-1477-2019 | Class II | Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620 | Zimmer GmbH | HTW | |
| Z-1476-2019 | Class II | Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619 | Zimmer GmbH | HTW | |
| Z-1475-2019 | Class II | Drill, cannulated, 4x150mm, AO, Item Number ST502015403 | Zimmer GmbH | HTW |