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-1575-2022 | Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF... | Baxter Healthcare Corporation | KYX | |
| Z-1509-2022 | Class II | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS... | Corin Limited | JDI | |
| Z-1763-2022 | Class I | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... | Cardiac Assist, Inc | DWA | |
| Z-1810-2022 | Class II | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822... | Unomedical A/S | FPA | |
| Z-1683-2022 | Class II | Medline CHEST TUBE REORDER NO: DYNJ36762A | MEDLINE INDUSTRIES, LP - Northfield | LRP | |
| Z-1568-2022 | Class II | Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory... | Maquet Cardiovascular Us Sales, LLC | CBK | |
| Z-1751-2022 | Class II | iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash... | Alcor Scientific LLC | GKB | |
| Z-1652-2022 | Class II | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Qiagen | OWD | |
| Z-1651-2022 | Class II | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 | Qiagen | OWD | |
| Z-1650-2022 | Class II | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 | Qiagen | OWD | |
| Z-1559-2022 | Class II | EVIS EXERA III Bronchovideoscope | Aizu Olympus Co., Ltd. | EOQ | |
| Z-1564-2022 | Class II | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | bioMerieux, Inc. | PPM | |
| Z-1560-2022 | Class I | Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n... | Maquet Cardiovascular Us Sales, LLC | CBK | |
| Z-1052-2023 | Class III | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US... | NuVasive Inc | OLO | |
| Z-1718-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1717-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1716-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1715-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1714-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1713-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1712-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER... | Cook Incorporated | DQX | |
| Z-1711-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)... | Cook Incorporated | DQX | |
| Z-1710-2022 | Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER... | Cook Incorporated | DQX | |
| Z-1709-2022 | Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER... | Cook Incorporated | DQX | |
| Z-1708-2022 | Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER... | Cook Incorporated | DQX | |
| Z-1707-2022 | Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER... | Cook Incorporated | DQX | |
| Z-1706-2022 | Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER... | Cook Incorporated | DQX | |
| Z-1676-2022 | Class II | VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461 | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1675-2022 | Class II | VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1518-2022 | Class II | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | Abbott Molecular, Inc. | MZP | |
| Z-1523-2022 | Class II | Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. | Myolyn Inc. | GZI | |
| Z-1648-2022 | Class II | Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the... | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-1555-2022 | Class II | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer... | Becton Dickinson & Co | ONB | |
| Z-1638-2022 | Class II | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and... | Aesculap Inc | NKB | |
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal... | GE Healthcare | LLZ | |
| Z-1562-2022 | Class II | DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF... | DeRoyal Industries, Inc. | FMQ | |
| Z-1007-2026 | Class II | Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c... | Philips North America LLC | IYN | |
| Z-1524-2022 | Class II | ARIES SARS-CoV-2 Assay | Luminex Corporation | QJR | |
| Z-1515-2022 | Class II | cobas e801 Immunoassay Analyzer | Roche Diagnostics GmbH | JJE | |
| Z-1644-2022 | Class II | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System | Medtronic, Inc. | NIP | |
| Z-1570-2022 | Class II | The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is... | Baxter Healthcare Corporation | LHI | |
| Z-1516-2022 | Class II | Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number... | Aesculap Inc | FSO | |
| Z-1776-2022 | Class II | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use... | Paragon 28 | MBI | |
| Z-1569-2022 | Class II | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 | Materialise USA, LLC. | HWT | |
| Z-1640-2022 | Class II | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02... | bioMerieux, Inc. | NSX | |
| Z-1750-2022 | Class II | Surpria 64: Software Version V3.11, V3.22 | FUJIFILM Healthcare Americas Corporation | JAK | |
| Z-1749-2022 | Class II | Surpria: Software Version V3.11, V3.22 | FUJIFILM Healthcare Americas Corporation | JAK | |
| Z-1748-2022 | Class II | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | FUJIFILM Healthcare Americas Corporation | JAK | |
| Z-1667-2022 | Class II | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use... | Corin Limited | JDI | |
| Z-1558-2022 | Class III | AXIOM Sensis or Sensis Vibe Combo systems as follows: System... | Siemens Medical Solutions USA, Inc. | DQK |