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-1633-2020 | Class II | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX... | Physio Control, Inc. | MKJ | |
| Z-2063-2020 | Class II | Frames Direct Prescription Spectacle Lenses included in the frame brands | Frames Direct | HQG | |
| Z-1819-2020 | Class II | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG... | Mortara Instrument, Inc. | DPS | |
| Z-1818-2020 | Class II | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data... | Mortara Instrument, Inc. | DPS | |
| Z-1817-2020 | Class II | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG... | Mortara Instrument, Inc. | DPS | |
| Z-1816-2020 | Class II | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following... | Mortara Instrument, Inc. | DPS | |
| Z-1815-2020 | Class II | S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE... | Mortara Instrument, Inc. | DPS | |
| Z-1814-2020 | Class II | X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL... | Mortara Instrument, Inc. | DPS | |
| Z-1813-2020 | Class II | T12. Incorporates wireless electrocardiographic technology to achieve the real-time... | Mortara Instrument, Inc. | DPS | |
| Z-1812-2020 | Class II | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT... | Mortara Instrument, Inc. | DPS | |
| Z-1811-2020 | Class II | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with... | Mortara Instrument, Inc. | DPS | |
| Z-1810-2020 | Class II | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI... | Mortara Instrument, Inc. | DPS | |
| Z-2249-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | Radiometer Medical ApS | GIO | |
| Z-2248-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | Radiometer Medical ApS | GIO | |
| Z-2247-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | Radiometer Medical ApS | GIO | |
| Z-2161-2020 | Class II | Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) | Applied Medical Resources Corp | NWV | |
| Z-2160-2020 | Class II | Dr. Thames - Lap Chole, Ref: K0880, UDI: (01)30607915139620 | Applied Medical Resources Corp | NWV | |
| Z-2159-2020 | Class II | Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI... | Applied Medical Resources Corp | NWV | |
| Z-2158-2020 | Class II | Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI... | Applied Medical Resources Corp | NWV | |
| Z-1689-2020 | Class II | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile... | Bard Peripheral Vascular Inc | KNW | |
| Z-1789-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1788-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1787-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1786-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1785-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1784-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1783-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1782-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1781-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1780-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1779-2020 | Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product... | Degania Medical Devices Pvt. Ltd. | EZL | |
| Z-1757-2020 | Class II | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 | Smith & Nephew, Inc. | MBI | |
| Z-1756-2020 | Class II | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Smith & Nephew, Inc. | MBI | |
| Z-1946-2020 | Class II | PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number... | Becton Dickinson & Co | PND | |
| Z-1753-2020 | Class II | RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors... | Rayner Intraocular Lenses Limited | MSS | |
| Z-1747-2020 | Class I | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in... | Vascular Solutions LLC | DQO | |
| Z-1822-2020 | Class II | CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit | Halyard Health | PSG | |
| Z-1707-2020 | Class II | Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from... | Life Technologies Corporation | PQP | |
| Z-1706-2020 | Class II | Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from... | Life Technologies Corporation | PQP | |
| Z-1705-2020 | Class II | Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from... | Life Technologies Corporation | PQP | |
| Z-1704-2020 | Class II | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from... | Life Technologies Corporation | PQP | |
| Z-0444-2021 | Class II | SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended... | Aesthetics Biomedical, Inc. | OUH | |
| Z-1750-2020 | Class II | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number... | Zimmer GmbH | PHX | |
| Z-1749-2020 | Class II | Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1748-2020 | Class II | Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1714-2020 | Class II | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. | Greiner Bio-One North America, Inc. | GIM | |
| Z-1796-2020 | Class II | PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT | Merit Medical Systems, Inc. | DXC | |
| Z-1742-2020 | Class II | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2... | bioMerieux, Inc. | N/A | |
| Z-1718-2020 | Class II | Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a... | Boddingtons Plastics, Ltd. | FED | |
| Z-0103-2022 | Class II | smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 | Abbott Medical | DRO |