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-0581-2013 | Class II | SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0580-2013 | Class II | SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0579-2013 | Class II | SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0578-2013 | Class II | SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0577-2013 | Class II | SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0576-2013 | Class II | SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0575-2013 | Class II | SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0574-2013 | Class II | SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-0573-2013 | Class II | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with... | Depuy Orthopaedics Inc. | LPH | |
| Z-1146-2015 | Class II | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is... | Highridge Medical, LLC | NKB | |
| Z-1785-2013 | Class II | Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable... | Abbott Medical | LGW | |
| Z-1079-2013 | Class II | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-0171-2014 | Class II | Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath... | Handicare USA, Inc. | FSA | |
| Z-1050-2017 | Class II | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and... | The Binding Site Group Ltd. | DEH | |
| Z-1706-2017 | Class II | Mobile Diagnostic X-Ray System with Digital Panel | Philips North America LLC | IZL | |
| Z-1919-2014 | Class II | ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended... | The Anspach Effort, Inc. | GEI | |
| Z-1918-2014 | Class II | ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This... | The Anspach Effort, Inc. | KWR | |
| Z-1917-2014 | Class II | ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This... | The Anspach Effort, Inc. | HBC | |
| Z-1916-2014 | Class II | ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This... | The Anspach Effort, Inc. | MBI | |
| Z-1915-2014 | Class II | ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be... | The Anspach Effort, Inc. | MBI | |
| Z-1914-2014 | Class II | ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx... | The Anspach Effort, Inc. | HRX | |
| Z-1913-2014 | Class II | ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx... | The Anspach Effort, Inc. | HBC | |
| Z-1912-2014 | Class II | ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia... | The Anspach Effort, Inc. | HBC | |
| Z-1911-2014 | Class II | ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia... | The Anspach Effort, Inc. | HBC | |
| Z-1910-2014 | Class II | ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia... | The Anspach Effort, Inc. | HBC | |
| Z-1909-2014 | Class II | ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This... | The Anspach Effort, Inc. | HBC | |
| Z-1908-2014 | Class II | ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is... | The Anspach Effort, Inc. | HBC | |
| Z-1907-2014 | Class II | ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended... | The Anspach Effort, Inc. | HBB | |
| Z-1906-2014 | Class II | ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to... | The Anspach Effort, Inc. | HBB | |
| Z-1905-2014 | Class II | ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty... | The Anspach Effort, Inc. | HBC | |
| Z-1904-2014 | Class II | ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device... | The Anspach Effort, Inc. | HBC | |
| Z-1903-2014 | Class II | ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx... | The Anspach Effort, Inc. | GEY | |
| Z-1902-2014 | Class II | ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1901-2014 | Class II | ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to... | The Anspach Effort, Inc. | HBB | |
| Z-1900-2014 | Class II | ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device... | The Anspach Effort, Inc. | HBB | |
| Z-1899-2014 | Class II | ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a... | The Anspach Effort, Inc. | HBC | |
| Z-1898-2014 | Class II | ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended... | The Anspach Effort, Inc. | ERL | |
| Z-1897-2014 | Class II | ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used... | The Anspach Effort, Inc. | ERL | |
| Z-1896-2014 | Class II | ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This... | The Anspach Effort, Inc. | HBC | |
| Z-1895-2014 | Class II | ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx... | The Anspach Effort, Inc. | HBC | |
| Z-1894-2014 | Class II | ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom... | The Anspach Effort, Inc. | ERL | |
| Z-1893-2014 | Class II | ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx... | The Anspach Effort, Inc. | HBE | |
| Z-1892-2014 | Class II | ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This... | The Anspach Effort, Inc. | HBE | |
| Z-1891-2014 | Class II | ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used... | The Anspach Effort, Inc. | HBE | |
| Z-1890-2014 | Class II | ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1889-2014 | Class II | ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1888-2014 | Class II | ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This... | The Anspach Effort, Inc. | HBE | |
| Z-1887-2014 | Class II | ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is... | The Anspach Effort, Inc. | HBE | |
| Z-1886-2014 | Class II | ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device... | The Anspach Effort, Inc. | HBE | |
| Z-1885-2014 | Class II | ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx... | The Anspach Effort, Inc. | HBE |