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-1772-2025 | Class II | Intera 1.0T Omni/Stellar, Model Number: 781102; | Philips Medical Systems Nederland B.V. | LNH | |
| Z-1771-2025 | Class II | Intera 0.5T Standard, Model Number: 781101; | Philips Medical Systems Nederland B.V. | LNH | |
| Z-1770-2025 | Class II | Enterprise 1.5T, Model Number: 781145; | Philips Medical Systems Nederland B.V. | LNH | |
| Z-1719-2025 | Class II | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 | MEDLINE INDUSTRIES, LP - Northfield | MHI | |
| Z-1689-2025 | Class II | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are... | Boston Scientific Corporation | GEH | |
| Z-1688-2025 | Class II | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are... | Boston Scientific Corporation | GEH | |
| Z-1687-2025 | Class II | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are... | Boston Scientific Corporation | GEH | |
| Z-1686-2025 | Class II | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are... | Boston Scientific Corporation | GEH | |
| Z-1649-2025 | Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203... | Zimmer GmbH | LZO | |
| Z-1648-2025 | Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202... | Zimmer GmbH | LZO | |
| Z-1647-2025 | Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201... | Zimmer GmbH | LZO | |
| Z-1646-2025 | Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number... | Zimmer GmbH | LZO | |
| Z-1645-2025 | Class II | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number... | Zimmer GmbH | LZO | |
| Z-1560-2025 | Class II | Welch Allyn CP150 Electrocardiograph: | Baxter Healthcare Corporation | DPS | |
| Z-1559-2025 | Class II | Welch Allyn CONNEX Accessory Power Management Stand: | Baxter Healthcare Corporation | MWI | |
| Z-1558-2025 | Class II | Welch Allyn Connex Vital Signs Monitor (CVSM): | Baxter Healthcare Corporation | MHX | |
| Z-2192-2025 | Class II | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | Phasor Health, LLC | HBE | |
| Z-1820-2025 | Class II | Oec 3D | GE Healthcare | OXO | |
| Z-1819-2025 | Class II | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital... | GE Healthcare | OXO | |
| Z-1638-2025 | Class I | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1637-2025 | Class I | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1636-2025 | Class I | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1635-2025 | Class I | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1634-2025 | Class I | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1633-2025 | Class I | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1632-2025 | Class I | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1631-2025 | Class I | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1630-2025 | Class I | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1629-2025 | Class I | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1628-2025 | Class I | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1627-2025 | Class I | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1626-2025 | Class I | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1625-2025 | Class I | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1624-2025 | Class I | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | GE Medical Systems China Co., Ltd. | BSZ | |
| Z-1659-2025 | Class II | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90... | Radiometer Medical ApS | CHL | |
| Z-1568-2025 | Class II | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN... | Baxter Healthcare Corporation | DXQ | |
| Z-1567-2025 | Class II | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as... | Baxter Healthcare Corporation | DXQ | |
| Z-1566-2025 | Class II | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X... | Baxter Healthcare Corporation | DXQ | |
| Z-1565-2025 | Class II | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2)... | Baxter Healthcare Corporation | MWI | |
| Z-1564-2025 | Class II | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product... | Baxter Healthcare Corporation | DXQ | |
| Z-1563-2025 | Class II | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2)... | Baxter Healthcare Corporation | MHX | |
| Z-1562-2025 | Class II | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2)... | Baxter Healthcare Corporation | DXQ | |
| Z-1665-2025 | Class II | The Alinity m System is designed to automate the steps for nucleic acid testing. Model... | Abbott Molecular, Inc. | OOI | |
| Z-1784-2025 | Class II | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1584-2025 | Class II | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... | Channel Medsystems | MNB | |
| Z-1544-2025 | Class II | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female... | Agilent Technologies, Inc. | PFX | |
| Z-1622-2025 | Class II | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in... | Maquet Cardiovascular LLC | GEI | |
| Z-1714-2025 | Class II | Medline procedure kits, labeled as: HAND, REF DYNJ902002J | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1713-2025 | Class II | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K | MEDLINE INDUSTRIES, LP - Northfield | OJK | |
| Z-1712-2025 | Class II | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A | MEDLINE INDUSTRIES, LP - Northfield | NSB |