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-0455-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0454-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0453-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0452-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0451-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0450-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0449-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0448-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0447-2023 | Class I | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0446-2023 | Class I | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0445-2023 | Class I | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0444-2023 | Class I | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0346-2023 | Class II | Accelerate PhenoTest BC kit REF 10102018 | Accelerate Diagnostics, Inc. | PRH | |
| Z-0345-2023 | Class II | Accelerate PhenoTest BC kit REF 10101018 | Accelerate Diagnostics, Inc. | PRH | |
| Z-0282-2023 | Class II | VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam... | Visionsense, Ltd. | OWN | |
| Z-0281-2023 | Class II | VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS)... | Visionsense, Ltd. | OWN | |
| Z-0280-2023 | Class II | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product... | Visionsense, Ltd. | OWN | |
| Z-0443-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0442-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0441-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0440-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0439-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0438-2023 | Class I | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0437-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0436-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0435-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0434-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0433-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0432-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0431-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0430-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0429-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0428-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0427-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0426-2023 | Class I | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-0241-2023 | Class II | GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform... | STERIS Corporation | GEI | |
| Z-0154-2023 | Class I | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final... | Insulet Corporation | LZG | |
| Z-0234-2023 | Class II | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF... | Sonendo Inc | ELC | |
| Z-0233-2023 | Class II | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Sonendo Inc | ELC | |
| Z-0244-2023 | Class II | Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP... | Medtronic Navigation, Inc | ONO | |
| Z-0239-2023 | Class II | Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-0221-2023 | Class II | Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures... | Spectranetics Corp. | LPC | |
| Z-0220-2023 | Class II | VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro... | Ortho-Clinical Diagnostics, Inc. | DKB | |
| Z-0232-2023 | Class II | BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification... | Becton Dickinson & Co | LON | |
| Z-0149-2023 | Class II | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a... | Boston Scientific Corporation | QEY | |
| Z-0274-2023 | Class II | BASIN SET, MEBS42K, general surgical kit | American Contract Systems, Inc. | LRO | |
| Z-0765-2023 | Class II | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247... | Medical Action Industries, Inc. 306 | KDC | |
| Z-0464-2023 | Class II | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile... | Medical Action Industries, Inc. 306 | OWL | |
| Z-0246-2023 | Class II | OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a... | Novapproach Spine LLC | OVD | |
| Z-0268-2023 | Class II | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | Abbott Molecular, Inc. | OOI |