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-2075-2021 | Class II | PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003... | C-Rad Positioning AB | IYE | |
| Z-0614-2021 | Class II | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument... | Carl Zeiss Meditec Inc | HKO | |
| Z-0613-2021 | Class II | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for... | Carl Zeiss Meditec Inc | HLM | |
| Z-2943-2020 | Class II | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend... | Talladium Inc | EIH | |
| Z-2944-2020 | Class II | Merge PACS | Merge Healthcare Incorporated | LLZ | |
| Z-2979-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software... | Life Technologies Corporation | QJR | |
| Z-2978-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software... | Life Technologies Corporation | QJR | |
| Z-0448-2021 | Class II | Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN... | Shanghai United Imaging Healthcare Co., Ltd. | KPS | |
| Z-0447-2021 | Class II | Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product... | Shanghai United Imaging Healthcare Co., Ltd. | JAK | |
| Z-0446-2021 | Class II | Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product... | Shanghai United Imaging Healthcare Co., Ltd. | JAK | |
| Z-0445-2021 | Class II | Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product... | Shanghai United Imaging Healthcare Co., Ltd. | JAK | |
| Z-2990-2020 | Class II | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | Hologic, Inc. | NSU | |
| Z-2955-2020 | Class II | Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the... | Integra LifeSciences Corporation | GFD | |
| Z-2954-2020 | Class II | Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of... | Integra LifeSciences Corporation | GFD | |
| Z-2953-2020 | Class II | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a... | Integra LifeSciences Corporation | GFD | |
| Z-2910-2020 | Class I | PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD... | CareFusion 303, Inc | FRN | |
| Z-2882-2020 | Class I | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module... | CareFusion 303, Inc | FRN | |
| Z-2935-2020 | Class II | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive... | CareFusion 303, Inc | PHC | |
| Z-2939-2020 | Class I | BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly... | CareFusion 303, Inc | FRN | |
| Z-2909-2020 | Class I | Alaris System PC Unit Model 8015 | CareFusion 303, Inc | FRN | |
| Z-0049-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13... | Riverpoint Medical, LLC | GAM | |
| Z-0048-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14... | Riverpoint Medical, LLC | GAM | |
| Z-0047-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25... | Riverpoint Medical, LLC | GAM | |
| Z-0046-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12... | Riverpoint Medical, LLC | GAM | |
| Z-0045-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30"... | Riverpoint Medical, LLC | GAM | |
| Z-0044-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12... | Riverpoint Medical, LLC | GAM | |
| Z-0043-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15... | Riverpoint Medical, LLC | GAM | |
| Z-0042-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36"... | Riverpoint Medical, LLC | GAM | |
| Z-0041-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30"... | Riverpoint Medical, LLC | GAM | |
| Z-0040-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12... | Riverpoint Medical, LLC | GAM | |
| Z-0039-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36"... | Riverpoint Medical, LLC | GAM | |
| Z-0038-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30"... | Riverpoint Medical, LLC | GAM | |
| Z-0037-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11... | Riverpoint Medical, LLC | GAM | |
| Z-0036-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21... | Riverpoint Medical, LLC | GAM | |
| Z-0035-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12... | Riverpoint Medical, LLC | GAM | |
| Z-0034-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0033-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34... | Riverpoint Medical, LLC | GAM | |
| Z-0032-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0031-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11... | Riverpoint Medical, LLC | GAM | |
| Z-0030-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0029-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12... | Riverpoint Medical, LLC | GAM | |
| Z-0028-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23... | Riverpoint Medical, LLC | GAM | |
| Z-0027-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21... | Riverpoint Medical, LLC | GAM | |
| Z-0026-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20... | Riverpoint Medical, LLC | GAM | |
| Z-0025-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12... | Riverpoint Medical, LLC | GAM | |
| Z-0024-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25... | Riverpoint Medical, LLC | GAM | |
| Z-0023-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10... | Riverpoint Medical, LLC | GAM | |
| Z-0022-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0021-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0020-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12... | Riverpoint Medical, LLC | GAM |