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-2815-2017 | Class II | Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2814-2017 | Class II | Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2813-2017 | Class II | Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2812-2017 | Class II | Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2811-2017 | Class II | Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2810-2017 | Class II | Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2809-2017 | Class II | Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2808-2017 | Class II | Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2807-2017 | Class II | Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2806-2017 | Class II | Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2805-2017 | Class II | Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The... | Intl. Medsurg Connection, Inc. | FMI | |
| Z-2804-2017 | Class II | Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or... | Intl. Medsurg Connection, Inc. | KZH | |
| Z-2866-2017 | Class II | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F... | Xintec Corporation | GEX | |
| Z-3018-2017 | Class II | Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee... | Exactech, Inc. | MDM | |
| Z-0802-2018 | Class II | AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0801-2018 | Class II | AVID TruCustom SPINE convenience kits, Item Code: LITT016-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0800-2018 | Class II | AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0799-2018 | Class II | AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0798-2018 | Class II | AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0797-2018 | Class II | AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0796-2018 | Class II | AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0795-2018 | Class II | AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0794-2018 | Class II | AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0793-2018 | Class II | AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0792-2018 | Class II | AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0791-2018 | Class II | AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0790-2018 | Class II | AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0789-2018 | Class II | AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0788-2018 | Class II | AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0787-2018 | Class II | AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0786-2018 | Class II | AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0785-2018 | Class II | AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0784-2018 | Class II | AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0783-2018 | Class II | AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0782-2018 | Class II | AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0781-2018 | Class II | AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0780-2018 | Class II | AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0726-2018 | Class II | The GC80 Digital X-ray Imaging System | Samsung HME America, Inc. | KPR | |
| Z-2768-2017 | Class II | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach... | Medtronic Perfusion Systems | DXS | |
| Z-2767-2017 | Class II | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to... | Medtronic Perfusion Systems | DWF | |
| Z-2766-2017 | Class II | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring... | Medtronic Perfusion Systems | DWF | |
| Z-2765-2017 | Class II | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in... | Medtronic Perfusion Systems | DTL | |
| Z-2764-2017 | Class II | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during... | Medtronic Perfusion Systems | DTL | |
| Z-2803-2017 | Class II | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid... | Ortho-Clinical Diagnostics, Inc. | PFQ | |
| Z-0576-2018 | Class II | Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin... | B Braun Medical Inc | FMI | |
| Z-0575-2018 | Class II | Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior... | B Braun Medical Inc | FMI | |
| Z-0574-2018 | Class II | Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of... | B Braun Medical Inc | FMI | |
| Z-0573-2018 | Class II | Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of... | B Braun Medical Inc | FMI | |
| Z-0572-2018 | Class II | PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the... | B Braun Medical Inc | FMI | |
| Z-0571-2018 | Class II | Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083... | B Braun Medical Inc | FMI |