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-1249-2023 | Class II | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90... | Scientia Vascular | DQY | |
| Z-1217-2023 | Class II | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic... | HeartSine Technologies Ltd | MKJ | |
| Z-1253-2023 | Class II | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 | BioFire Diagnostics, LLC | PCH | |
| Z-1252-2023 | Class II | In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 | BioFire Diagnostics, LLC | QOF | |
| Z-1251-2023 | Class II | In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 | BioFire Diagnostics, LLC | PEN | |
| Z-1227-2023 | Class II | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity... | Aniara Diagnostica LLC | GGP | |
| Z-1226-2023 | Class III | PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in... | PREAT Corporation | EMA | |
| Z-1213-2023 | Class II | Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to... | Baxter Healthcare Corporation | KDJ | |
| Z-1244-2023 | Class II | BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for... | Becton Dickinson & Co | FMF | |
| Z-1243-2023 | Class II | BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for... | Becton Dickinson & Co | FMF | |
| Z-1242-2023 | Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit... | Becton Dickinson & Co | FMF | |
| Z-1241-2023 | Class II | BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for... | Becton Dickinson & Co | FMF | |
| Z-1240-2023 | Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for... | Becton Dickinson & Co | FMF | |
| Z-1239-2023 | Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit... | Becton Dickinson & Co | FMF | |
| Z-1238-2023 | Class II | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit... | Becton Dickinson & Co | FMF | |
| Z-1237-2023 | Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for... | Becton Dickinson & Co | FMF | |
| Z-1206-2023 | Class II | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in... | Eastman Kodak Company | KPR | |
| Z-1258-2023 | Class II | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the... | Siemens Healthcare Diagnostics Inc. | MLM | |
| Z-1245-2023 | Class II | Fusion Bioline Vascular Graft, Part number M00201503046B0 | Maquet Cardiovascular LLC | DSY | |
| Z-1236-2023 | Class II | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and... | Medtronic, Inc. | KCT | |
| Z-1210-2023 | Class II | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656... | DiaSorin Molecular LLC | OCC | |
| Z-1209-2023 | Class II | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with... | DiaSorin Molecular LLC | QJR | |
| Z-1271-2023 | Class II | Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-1270-2023 | Class II | Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-1269-2023 | Class II | Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination... | Siemens Healthcare Diagnostics Inc. | CEK | |
| Z-1268-2023 | Class II | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination... | Siemens Healthcare Diagnostics Inc. | MRR | |
| Z-1198-2023 | Class II | Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) | CooperVision, Inc. | LPM | |
| Z-1197-2023 | Class II | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) | CooperVision, Inc. | LPM | |
| Z-1257-2023 | Class II | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1350-2023 | Class II | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of... | Church & Dwight Co., Inc. | LCX | |
| Z-1228-2023 | Class II | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT | Medtronic, Inc. | GDW | |
| Z-1261-2023 | Class II | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the... | Limacorporate S.p.A. | JDC | |
| Z-1186-2023 | Class II | Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of... | Stryker Corp. | PBZ | |
| Z-1185-2023 | Class II | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog... | Stryker Corp. | PBZ | |
| Z-1184-2023 | Class II | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog... | Stryker Corp. | PBZ | |
| Z-1142-2023 | Class I | Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals | Baxter Healthcare Corporation | CBK | |
| Z-1141-2023 | Class I | Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory... | Baxter Healthcare Corporation | CBK | |
| Z-1140-2023 | Class I | Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support... | Baxter Healthcare Corporation | CBK | |
| Z-1139-2023 | Class I | Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support... | Baxter Healthcare Corporation | CBK | |
| Z-1351-2023 | Class II | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation... | Outset Medical, Inc. | FIP | |
| Z-1192-2023 | Class II | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP... | CareFusion 303, Inc | FRN | |
| Z-1262-2023 | Class II | Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X... | Intuitive Surgical, Inc. | NAY | |
| Z-1138-2023 | Class I | NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size... | Draeger, Inc. | CBK | |
| Z-1137-2023 | Class I | NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577... | Draeger, Inc. | CBK | |
| Z-1360-2026 | Class III | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | |
| Z-1359-2026 | Class III | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | |
| Z-1358-2026 | Class III | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | |
| Z-1357-2026 | Class III | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | |
| Z-1356-2026 | Class III | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | |
| Z-0121-2024 | Class II | SenSight Connector Plug, Model Number B31061. | Medtronic Neuromodulation | MHY |