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-2411-2020 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-2410-2020 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-2409-2020 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-2408-2020 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-2466-2020 | Class II | Respirator Crash Cart Kit | ROi CPS LLC | OEV | |
| Z-2465-2020 | Class II | Isolation Droplet Bundle Kit | ROi CPS LLC | OEA | |
| Z-2337-2020 | Class II | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1... | Philips North America LLC | DPS | |
| Z-2424-2020 | Class II | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE... | GE Healthcare | MHX | |
| Z-2400-2020 | Class II | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades. | Medtronic, Inc. | EMF | |
| Z-2353-2020 | Class II | RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2352-2020 | Class II | RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2351-2020 | Class II | RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2350-2020 | Class II | RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2349-2020 | Class II | RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2348-2020 | Class II | RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2347-2020 | Class II | RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2346-2020 | Class II | RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2345-2020 | Class II | RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2344-2020 | Class II | RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2343-2020 | Class II | RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2342-2020 | Class II | RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2341-2020 | Class II | RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2340-2020 | Class II | RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2339-2020 | Class II | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2530-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2529-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2528-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2527-2020 | Class II | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2526-2020 | Class II | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2525-2020 | Class II | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2524-2020 | Class II | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-2406-2020 | Class II | MEVION S250i, MEVION S250; Proton Radiation Treatment System | Mevion Medical Systems, Inc. | LHN | |
| Z-2438-2020 | Class II | (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... | Siemens Healthcare Diagnostics Inc. | N/A | |
| Z-2437-2020 | Class II | (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number... | Siemens Healthcare Diagnostics Inc. | N/A | |
| Z-2470-2020 | Class II | Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2469-2020 | Class II | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2441-2020 | Class II | DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign... | Mediana Co., Ltd. | DXN | |
| Z-2639-2020 | Class II | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product... | Neocis Inc. | PLV | |
| Z-2638-2020 | Class II | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product... | Neocis Inc. | PLV | |
| Z-2637-2020 | Class II | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product... | Neocis Inc. | PLV | |
| Z-2532-2020 | Class II | Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number... | Bound Tree Medical, LLC | CAE | |
| Z-2324-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2323-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2322-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2321-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2320-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2319-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2318-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2317-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number... | Zimmer GmbH | HRS | |
| Z-2316-2020 | Class II | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number... | Zimmer GmbH | HRS |