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-1418-05 | Gemini 16 PET/CT sytem, Slice Configuration | Philips North America LLC | JAK | ||
| Z-1417-05 | Gemini PET/CT sytem, Dual Configuration | Philips North America LLC | JAK | ||
| Z-1416-05 | MxView using version 5.0, 5.0.1, or 4.1 software. | Philips North America LLC | JAK | ||
| Z-1415-05 | Extended Brilliance Workspace using 1.x or 2.x software. | Philips North America LLC | JAK | ||
| Z-1414-05 | MX8000 Dual v.EXP CT scanner using Version 2.5 software. | Philips North America LLC | JAK | ||
| Z-1413-05 | MX8000IDT CT Scanner using version 2.5.5, 3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software. | Philips North America LLC | JAK | ||
| Z-1412-05 | Brillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2... | Philips North America LLC | JAK | ||
| Z-1411-05 | Brillance 16, 10, and 6 configuration (watercooled version) using 1.0, 1.1, 1.2, 1.2.2... | Philips North America LLC | JAK | ||
| Z-1410-05 | Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software. | Philips North America LLC | JAK | ||
| Z-1409-05 | Brilliance CT System, 40 channel configuration using version 1.2 software. | Philips North America LLC | JAK | ||
| Z-0879-05 | Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem... | Perkin Elmer Life and Analytical | NQL | ||
| Z-0783-05 | ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and... | Abbott Medical | CGN | ||
| Z-0855-05 | Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use... | Arizant Healthcare, Inc. | DWJ | ||
| Z-0709-05 | Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+... | Abbott Medical | NIK | ||
| Z-0981-05 | Clinician Workstation Software, product code 2M5042 | Baxter Healthcare Corporation | LNX | ||
| Z-0816-05 | Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West... | Del Medical, Inc. | IYB | ||
| Z-2055-2008 | OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a... | Howmedica Osteonics Corp | HWT | ||
| Z-2054-2008 | OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern... | Howmedica Osteonics Corp | HWT | ||
| Z-0723-05 | Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N... | Intuitive Surgical, Inc. | LRW | ||
| Z-0696-05 | Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S. | Centurion Medical Products, LP | KZH | ||
| Z-0712-05 | MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant... | Porex Surgical, Inc. | HPZ | ||
| Z-0843-05 | Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 | bioMerieux, Inc. | GJS | ||
| Z-0708-05 | Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The... | Trek Diagnostic Systems, Ltd. | MDB | ||
| Z-0660-05 | IMx HAVAB Controls In Vitro Test | Abbott Diagnostic International, Ltd. | LOL | ||
| Z-0722-05 | Allen A-91000 Shoulder Positioner | Allen Medical Systems, Inc. | FWZ | ||
| Z-0554-05 | Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0854-05 | Baxter Extension Sets with PosiFlow Access Device for IV Access; product codes 2N9051... | Baxter Healthcare Corporation | FPA | ||
| Z-0853-05 | Baxter PosiFlow Access Device for IV Access; product code 2N9050; a single use, sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1262-06 | Radiance Data Management System Software Version 2.42 (Stand-alone software package) for... | Radiometer America, Inc | JQP | ||
| Z-0778-05 | Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code... | Baxter Healthcare Corporation | FRN | ||
| Z-0661-05 | Hill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900. | Hill-Rom Inc. | FNL | ||
| Z-0008-06 | ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. | Abbott Medical | JJE | ||
| Z-0657-05 | ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are... | Ethicon Endo-Surgery Inc | FZP | ||
| Z-0656-05 | ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten... | Ethicon Endo-Surgery Inc | FZP | ||
| Z-0655-05 | ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are... | Ethicon Endo-Surgery Inc | FZP | ||
| Z-0654-05 | ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are... | Ethicon Endo-Surgery Inc | FZP | ||
| Z-0616-05 | MurphyScope, Curved, Mallaeble, Catalog # 2125-163 | Medtronic Neurosurgery | GWG | ||
| Z-0615-05 | MurphyScope, Bayonet, Malleable, Catalog # 2121-157 | Medtronic Neurosurgery | GWG | ||
| Z-0798-05 | MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages | U.S. Filter/Ionpure, Inc. | FIP | ||
| Z-0845-05 | Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink... | Baxter Healthcare Corporation | FPA | ||
| Z-1544-05 | Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0782-05 | Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO... | Boston Scientific Corporation | LLD | ||
| Z-0781-05 | Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236... | Boston Scientific Corporation | LLD | ||
| Z-0780-05 | Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO... | Boston Scientific Corporation | LLD | ||
| Z-1543-05 | Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1084-05 | Optimus 30 | Philips North America LLC | KPR | ||
| Z-0027-05 | Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile... | Bioteque America Inc | |||
| Z-0653-05 | Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics... | Compumedics USA, Inc. | GWQ | ||
| Z-0652-05 | Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02... | Compumedics USA, Inc. | GWQ | ||
| Z-1105-2008 | Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog... | Howmedica Osteonics Corp | HWA |