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-1596-2021 | Class II | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in... | Roche Diagnostics GmbH | MMI | |
| Z-1595-2021 | Class II | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to... | Roche Diagnostics GmbH | MMI | |
| Z-1669-2021 | Class II | REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1668-2021 | Class II | REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1667-2021 | Class II | REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System... | Bard Access Systems, Inc. | LJS | |
| Z-1666-2021 | Class II | REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1665-2021 | Class II | REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System... | Bard Access Systems, Inc. | LJS | |
| Z-1664-2021 | Class II | REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1663-2021 | Class II | REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1662-2021 | Class II | REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1661-2021 | Class II | REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1660-2021 | Class II | REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1659-2021 | Class II | REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)... | Bard Access Systems, Inc. | LJS | |
| Z-1658-2021 | Class II | REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg... | Bard Access Systems, Inc. | LJS | |
| Z-1657-2021 | Class II | REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1656-2021 | Class II | REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1655-2021 | Class II | REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60... | Bard Access Systems, Inc. | LJS | |
| Z-1654-2021 | Class II | REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1653-2021 | Class II | REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI... | Bard Access Systems, Inc. | LJS | |
| Z-1652-2021 | Class II | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm... | Bard Access Systems, Inc. | LJS | |
| Z-1630-2021 | Class II | BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169 | Respironics, Inc. | MNT | |
| Z-1629-2021 | Class II | BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143 | Respironics, Inc. | MNS | |
| Z-1628-2021 | Class II | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number... | Respironics, Inc. | MNT | |
| Z-1627-2021 | Class II | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number... | Respironics, Inc. | MNT | |
| Z-1626-2021 | Class II | BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169 | Respironics, Inc. | MNT | |
| Z-1625-2021 | Class II | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number... | Respironics, Inc. | MNS | |
| Z-1529-2021 | Class II | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage... | LeMaitre Vascular Inc. | DXT | |
| Z-1528-2021 | Class II | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to... | Medtronic, Inc. | NIK | |
| Z-1527-2021 | Class II | Programmers - Product Usage: used to treat arrhythmias related to bradycardia... | Medtronic, Inc. | NIK | |
| Z-1526-2021 | Class II | Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to... | Medtronic, Inc. | NIK | |
| Z-1525-2021 | Class II | Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to... | Medtronic, Inc. | NIK | |
| Z-1523-2021 | Class II | CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b... | Medtronic, Inc. | NKE | |
| Z-1522-2021 | Class II | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable... | Medtronic, Inc. | OSR | |
| Z-1593-2021 | Class II | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts... | W. L. Gore & Associates, Inc. | FGE | |
| Z-1782-2021 | Class II | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx... | Clinical Laserthermia Systems AB | GEX | |
| Z-1781-2021 | Class II | Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage... | Clinical Laserthermia Systems AB | GEA | |
| Z-1780-2021 | Class II | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the... | Clinical Laserthermia Systems AB | GAH | |
| Z-1436-2021 | Class II | DirectInject consists of a sterile dual paste system which is calcium phosphate based... | Stryker Leibinger GmbH & Co. KG | GXP | |
| Z-1505-2021 | Class II | Scooter | Merits Health Products, Inc. | INI | |
| Z-1504-2021 | Class II | Power Wheelchair | Merits Health Products, Inc. | ITI | |
| Z-2098-2021 | Class II | SoftCytogenetics | SCC Soft Computer | JQP | |
| Z-2093-2021 | Class II | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information... | SCC Soft Computer | JQP | |
| Z-1485-2021 | Class II | AM12M Acquisition Module accessory. Impacted software version of the AM12M is version... | Mortara Instrument, Inc. | DPS | |
| Z-1484-2021 | Class II | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory... | Mortara Instrument, Inc. | DPS | |
| Z-1483-2021 | Class II | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software... | Mortara Instrument, Inc. | DPS | |
| Z-1481-2021 | Class II | Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of... | Abbott Medical | DRS | |
| Z-1482-2021 | Class II | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software... | Mortara Instrument, Inc. | DPS | |
| Z-1480-2021 | Class II | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF... | Abbott Medical | DRS | |
| Z-1479-2021 | Class II | HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH... | Abbott Medical | DRS | |
| Z-1478-2021 | Class II | HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds... | Abbott Medical | DRS |