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-2505-2023 | Class I | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5... | Abbott Medical | LGW | |
| Z-2629-2023 | Class II | Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during... | Novanta Medical GmbH | HIG | |
| Z-2464-2023 | Class II | RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1288-2024 | Class II | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile | Peter Lazic GmbH | HCH | |
| Z-1287-2024 | Class II | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile | Peter Lazic GmbH | HCH | |
| Z-0197-2024 | Class II | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic... | Quest Medical, Inc | FPA | |
| Z-2620-2023 | Class II | COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. | COPAN Diagnostics, Inc. | JRC | |
| Z-2641-2023 | Class II | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F... | Waldemar Link GmbH & Co. KG | LPH | |
| Z-0159-2024 | Class II | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children... | EMPATICA S.r.l. | POS | |
| Z-2578-2023 | Class II | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the... | Instrumentation Laboratory Co. | GKP | |
| Z-2468-2023 | Class II | The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be... | LeMaitre Vascular Inc. | MGZ | |
| Z-2582-2023 | Class II | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2430-2023 | Class II | Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414... | Abbott Medical | FRN | |
| Z-2429-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2428-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM... | Medtronic, Inc. | GCJ | |
| Z-2427-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2426-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2425-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2424-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM... | Medtronic, Inc. | GCJ | |
| Z-2423-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2422-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2421-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2420-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2419-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2418-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED... | Medtronic, Inc. | GCJ | |
| Z-2417-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED... | Medtronic, Inc. | GCJ | |
| Z-2416-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2415-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF... | Medtronic, Inc. | GCJ | |
| Z-2575-2023 | Class II | Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used... | Landauer | IYE | |
| Z-2574-2023 | Class II | NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR... | Landauer | IYE | |
| Z-2573-2023 | Class II | NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b)... | Landauer | IYE | |
| Z-2572-2023 | Class II | Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001)... | Landauer | IYE | |
| Z-2571-2023 | Class II | Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002)... | Landauer | IYE | |
| Z-2570-2023 | Class II | Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c)... | Landauer | IYE | |
| Z-2569-2023 | Class II | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET... | Landauer | IYE | |
| Z-2568-2023 | Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET... | Landauer | IYE | |
| Z-2567-2023 | Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET... | Landauer | IYE | |
| Z-2566-2023 | Class II | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c)... | Landauer | IYE | |
| Z-2565-2023 | Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c)... | Landauer | IYE | |
| Z-2564-2023 | Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c)... | Landauer | IYE | |
| Z-2563-2023 | Class II | nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring... | Landauer | IYE | |
| Z-2562-2023 | Class II | nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d)... | Landauer | IYE | |
| Z-2561-2023 | Class II | nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring... | Landauer | IYE | |
| Z-2560-2023 | Class II | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b)... | Landauer | IYE | |
| Z-2559-2023 | Class II | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006)... | Landauer | IYE | |
| Z-2558-2023 | Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b)... | Landauer | IYE | |
| Z-2557-2023 | Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003)... | Landauer | IYE | |
| Z-2556-2023 | Class II | nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring... | Landauer | IYE | |
| Z-2555-2023 | Class II | nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring... | Landauer | IYE | |
| Z-2554-2023 | Class II | nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring... | Landauer | IYE |