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-0872-2017 | Class II | 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive... | Stryker Corp. | HBE | |
| Z-0871-2017 | Class II | 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally... | Stryker Corp. | HBE | |
| Z-0870-2017 | Class II | 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally... | Stryker Corp. | HBE | |
| Z-0869-2017 | Class II | 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS... | Stryker Corp. | HBE | |
| Z-0868-2017 | Class II | 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS... | Stryker Corp. | HBE | |
| Z-0938-2017 | Class II | Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. | Boston Scientific Corporation | LWP | |
| Z-1204-2017 | Class II | CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-1012-2017 | Class II | symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G... | Symmetry Surgical GmbH | KCT | |
| Z-1011-2017 | Class II | symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP... | Symmetry Surgical GmbH | KCT | |
| Z-1010-2017 | Class II | symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135... | Symmetry Surgical GmbH | KCT | |
| Z-0867-2017 | Class II | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument | Synthes (USA) Products LLC | FSM | |
| Z-1078-2017 | Class II | Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN... | Sekisui Diagnostics P.E.I. Inc. | JIF | |
| Z-1088-2017 | Class II | Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air... | Atrium Medical Corporation | PAD | |
| Z-1087-2017 | Class II | Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection... | Atrium Medical Corporation | PAD | |
| Z-1086-2017 | Class II | Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery... | Atrium Medical Corporation | PAD | |
| Z-1085-2017 | Class II | Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient... | Atrium Medical Corporation | PAD | |
| Z-1084-2017 | Class II | Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain... | Atrium Medical Corporation | PAD | |
| Z-1083-2017 | Class II | Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line... | Atrium Medical Corporation | PAD | |
| Z-1082-2017 | Class II | Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery... | Atrium Medical Corporation | PAD | |
| Z-1081-2017 | Class II | Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean... | Atrium Medical Corporation | PAD | |
| Z-1080-2017 | Class II | Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber... | Atrium Medical Corporation | PAD | |
| Z-1079-2017 | Class II | Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line... | Atrium Medical Corporation | PAD | |
| Z-0252-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No... | Boston Scientific Corporation | LJS | |
| Z-0251-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No... | Boston Scientific Corporation | LJS | |
| Z-0250-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No... | Boston Scientific Corporation | LJS | |
| Z-0249-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No... | Boston Scientific Corporation | LJS | |
| Z-0248-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The... | Boston Scientific Corporation | LJS | |
| Z-0247-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The... | Boston Scientific Corporation | LJS | |
| Z-0246-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The... | Boston Scientific Corporation | LJS | |
| Z-0245-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The... | Boston Scientific Corporation | LJS | |
| Z-0244-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The... | Boston Scientific Corporation | LJS | |
| Z-0243-2018 | Class II | XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with... | Boston Scientific Corporation | LJS | |
| Z-0242-2018 | Class II | XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with... | Boston Scientific Corporation | LJS | |
| Z-0241-2018 | Class II | XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The... | Boston Scientific Corporation | LJS | |
| Z-0240-2018 | Class II | Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70... | Boston Scientific Corporation | LJS | |
| Z-0961-2017 | Class II | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0733-2017 | Class II | Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter... | Cook Incorporated | FOZ | |
| Z-1004-2017 | Class II | Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce... | Philips North America LLC | JAK | |
| Z-0989-2017 | Class II | i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy... | Omnicell, Inc. | NEP | |
| Z-1074-2017 | Class II | Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds | MEDLINE INDUSTRIES, LP - Northfield | FQM | |
| Z-0977-2017 | Class I | NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product... | bioMerieux, Inc. | PPM | |
| Z-0976-2017 | Class I | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS easyMAG system... | bioMerieux, Inc. | PPM | |
| Z-0958-2017 | Class II | Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory... | Straumann USA, LLC | NDP | |
| Z-0957-2017 | Class II | Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile. Dental implant... | Straumann USA, LLC | NDP | |
| Z-0899-2017 | Class II | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0... | Radiometer America, Inc | CHL | |
| Z-0928-2017 | Class II | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed... | Allen Medical Systems, Inc. | HST | |
| Z-0941-2017 | Class II | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06... | Interventional Spine, Inc. | MAX | |
| Z-0887-2017 | Class II | Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part... | Spinal Elements, Inc | KWQ | |
| Z-0886-2017 | Class II | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part... | Spinal Elements, Inc | KWQ | |
| Z-0883-2017 | Class II | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm... | Spinal Elements, Inc | MNH |