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-0295-2019 | Class II | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery... | Arthrex GmbH | HAB | |
| Z-0211-2020 | Class II | Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. | Siemens Healthcare Diagnostics Inc. | KNK | |
| Z-0210-2020 | Class II | Beckman Coulter Lipase, REF OSR6130 and OSR6230. | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-0118-2020 | Class II | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert... | Trimed Inc | HRS | |
| Z-1214-2019 | Class II | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the... | Trimed Inc | HRS | |
| Z-0361-2019 | Class II | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab... | Inpeco S.p.A. | JQP | |
| Z-0065-2019 | Class II | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The... | Vision Rt Inc | IYE | |
| Z-0174-2019 | Class II | Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 | Life Technologies Corporation | KIT | |
| Z-0173-2019 | Class II | Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use | Life Technologies Corporation | KIT | |
| Z-0172-2019 | Class II | Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 | Life Technologies Corporation | KIT | |
| Z-0171-2019 | Class II | Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro... | Life Technologies Corporation | KIT | |
| Z-3202-2018 | Class II | Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16... | ShinChang Medical Co., Ltd. | FMF | |
| Z-0467-2019 | Class II | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters... | Stryker Sustainability Solutions | NLH | |
| Z-0559-2019 | Class II | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay... | Tosoh Bioscience Inc | KHO | |
| Z-0384-2019 | Class II | BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog... | Becton Dickinson & Co | FOZ | |
| Z-0398-2019 | Class II | Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number... | Zimmer GmbH | GXN | |
| Z-0397-2019 | Class II | Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040... | Zimmer GmbH | GXN | |
| Z-0396-2019 | Class II | Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref... | Zimmer GmbH | GXN | |
| Z-0395-2019 | Class II | Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030... | Zimmer GmbH | GXN | |
| Z-0394-2019 | Class II | Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref... | Zimmer GmbH | GXN | |
| Z-0401-2019 | Class II | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads... | Safe N Simple, LLC | NAE | |
| Z-0400-2019 | Class II | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number... | Safe N Simple, LLC | NAE | |
| Z-0393-2019 | Class II | Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020... | Zimmer GmbH | GXN | |
| Z-1218-2019 | Class II | Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF... | Abbott Medical | FOZ | |
| Z-2279-2020 | Class II | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2278-2020 | Class II | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product... | Genicon, Inc. | GEA | |
| Z-2277-2020 | Class II | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage... | Genicon, Inc. | GEA | |
| Z-2276-2020 | Class II | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2275-2020 | Class II | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2274-2020 | Class II | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2273-2020 | Class II | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2272-2020 | Class II | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product... | Genicon, Inc. | GEA | |
| Z-2271-2020 | Class II | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product... | Genicon, Inc. | GEA | |
| Z-2270-2020 | Class II | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product... | Genicon, Inc. | GEA | |
| Z-2269-2020 | Class II | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2268-2020 | Class II | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product... | Genicon, Inc. | GEA | |
| Z-2267-2020 | Class II | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-2266-2020 | Class II | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded)... | Genicon, Inc. | GEA | |
| Z-0102-2019 | Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual... | OriGen Biomedical, Inc. | DWF | |
| Z-0376-2019 | Class II | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number... | Coltene /Whaledent AG | ELR | |
| Z-0012-2019 | Class II | Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery | Exactech, Inc. | KWT | |
| Z-0184-2019 | Class II | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen... | OriGen Biomedical, Inc. | DWF | |
| Z-0183-2019 | Class II | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The... | OriGen Biomedical, Inc. | DWF | |
| Z-0182-2019 | Class II | Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen... | OriGen Biomedical, Inc. | DWF | |
| Z-0181-2019 | Class II | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen... | OriGen Biomedical, Inc. | DWF | |
| Z-0180-2019 | Class II | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen... | OriGen Biomedical, Inc. | DWF | |
| Z-0179-2019 | Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual... | OriGen Biomedical, Inc. | DWF | |
| Z-0005-2019 | Class II | VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam... | Varian Medical Systems, Inc. | IYE | |
| Z-0004-2019 | Class II | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery... | Varian Medical Systems, Inc. | IYE | |
| Z-0069-2019 | Class II | ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28... | Abbott Medical | FMG |