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-1789-2021 | Class II | The Terumo HX2 Temperature Management System provides temperature control of two... | Terumo Cardiovascular Systems Corporation | DWC | |
| Z-1693-2021 | Class II | Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used... | Draeger, Inc. | CBK | |
| Z-1692-2021 | Class II | Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used... | Draeger, Inc. | CBK | |
| Z-1691-2021 | Class II | Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used... | Draeger, Inc. | CBK | |
| Z-1690-2021 | Class II | Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used... | Draeger, Inc. | CBK | |
| Z-1698-2021 | Class II | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HXX | |
| Z-1689-2021 | Class II | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product... | Vygon U.S.A. | OXQ | |
| Z-1560-2021 | Class II | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. | Haag-Streit USA Inc | HJO | |
| Z-1788-2021 | Class II | Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system | Arjo (Suzhou) Co., Ltd. | FNM | |
| Z-1491-2021 | Class II | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended... | Boston Scientific Corporation | OHD | |
| Z-1490-2021 | Class II | Colpassist Vaginal Positioning Device - Product Usage: intended for use in general... | Boston Scientific Corporation | KOH | |
| Z-2097-2021 | Class II | Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy... | Dutch Ophthalmic USA, Inc. | HQF | |
| Z-1858-2021 | Class II | E3800 PC Units (spare parts) | Radiometer Medical ApS | CEM | |
| Z-1857-2021 | Class II | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as... | Radiometer Medical ApS | CHL | |
| Z-1856-2021 | Class II | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare... | Radiometer Medical ApS | CEM | |
| Z-1684-2021 | Class II | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use... | Baxter Healthcare Corporation | FJK | |
| Z-1670-2021 | Class II | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b... | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-1774-2021 | Class II | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images... | Philips North America LLC | JAK | |
| Z-1514-2021 | Class II | DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681... | DJO, LLC | ILI | |
| Z-1513-2021 | Class II | DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674... | DJO, LLC | ILI | |
| Z-1512-2021 | Class II | DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01)... | DJO, LLC | ILI | |
| Z-1511-2021 | Class II | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product... | DJO, LLC | ILI | |
| Z-1592-2021 | Class I | VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter... | Boston Scientific Corporation | QAN | |
| Z-1591-2021 | Class I | VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions... | Boston Scientific Corporation | QAN | |
| Z-1975-2021 | Class II | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft... | Spineart SA | NKB | |
| Z-1559-2021 | Class I | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical Action Industries, Inc. 306 | OFZ | |
| Z-1558-2021 | Class I | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical Action Industries, Inc. 306 | OFM | |
| Z-1557-2021 | Class I | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical Action Industries, Inc. 306 | PEZ | |
| Z-1556-2021 | Class I | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical Action Industries, Inc. 306 | OFF | |
| Z-1555-2021 | Class I | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical Action Industries, Inc. 306 | OGJ | |
| Z-1554-2021 | Class I | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical Action Industries, Inc. 306 | PEZ | |
| Z-1787-2021 | Class I | DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-1786-2021 | Class I | FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number... | Avid Medical, Inc. a Medical Action Ind. Company 305 | OEZ | |
| Z-1785-2021 | Class I | FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-1784-2021 | Class I | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04 | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-1539-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 3T | Innova Medical Group, Inc. | QKP | |
| Z-1538-2021 | Class I | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen... | Innova Medical Group, Inc. | QKP | |
| Z-1537-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 7T | Innova Medical Group, Inc. | QKP | |
| Z-1971-2021 | Class II | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during... | Spes Medica S.P.A | ETN | |
| Z-1970-2021 | Class II | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact... | Spes Medica S.P.A | FAP | |
| Z-1969-2021 | Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference... | Spes Medica S.P.A | ETN | |
| Z-1968-2021 | Class II | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact... | Spes Medica S.P.A | FAP | |
| Z-1967-2021 | Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference... | Spes Medica S.P.A | ETN | |
| Z-1849-2021 | Class II | Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1848-2021 | Class II | Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1510-2021 | Class II | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference... | Smith & Nephew, Inc. | MAI | |
| Z-1541-2021 | Class II | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number... | Meridian Bioscience Inc | QJR | |
| Z-1540-2021 | Class II | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription... | Meridian Bioscience Inc | QJR | |
| Z-1598-2021 | Class II | RayStation standalone software radiation therapy treatment planning system. Model Number... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1650-2021 | Class II | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac... | Medtronic, Inc. | NIK |