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-0501-2018 | Class II | bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF... | Becton Dickinson & Co | EMF | |
| Z-0500-2018 | Class II | bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport... | Becton Dickinson & Co | EMF | |
| Z-0277-2018 | Class II | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm... | Stryker Corp. | NRY | |
| Z-0238-2018 | Class II | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0237-2018 | Class II | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0236-2018 | Class II | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0276-2018 | Class II | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm... | Stryker Corp. | NRY | |
| Z-0275-2018 | Class II | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm... | Stryker Corp. | NRY | |
| Z-0188-2018 | Class II | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to... | Medtronic, Inc. | NIP | |
| Z-0189-2018 | Class II | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF... | Volcano Corporation | OBJ | |
| Z-0172-2018 | Class II | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC... | Brainlab, Inc. | IYE | |
| Z-1077-2018 | Class II | Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding... | Epigenomics AG | PHP | |
| Z-1692-2018 | Class II | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers... | Wallac Oy | NQL | |
| Z-0193-2018 | Class II | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per... | Black Forest Medical GmbH | HBL | |
| Z-0209-2018 | Class II | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Remel Inc | JTZ | |
| Z-1741-2018 | Class II | ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The... | Microline Surgical, Inc | GEI | |
| Z-1740-2018 | Class II | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI... | Microline Surgical, Inc | GEI | |
| Z-0943-2018 | Class II | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System... | Ion Beam Applications S.A. | LHN | |
| Z-0522-2018 | Class II | Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron... | Philips North America LLC | KPS | |
| Z-0552-2018 | Class II | ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC... | 3M Company | NOC | |
| Z-0704-2019 | Class II | VariCam | GE Healthcare | KPS | |
| Z-0703-2019 | Class II | Discover VH/Millennium VG Nuclear Medicine Imaging System | GE Healthcare | KPS | |
| Z-0401-2018 | Class II | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump... | LivaNova Deutschland GmbH | DWA | |
| Z-0195-2018 | Class II | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a)... | Abbott Medical | FRN | |
| Z-0101-2018 | Class II | Plum 360 Infusion System, List number 30010. | Abbott Medical | FRN | |
| Z-0162-2020 | Class III | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium... | Xintec Corporation | GEX | |
| Z-2103-2018 | Class II | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals... | NordicNeuroLab AS | LNH | |
| Z-1195-2018 | Class II | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro... | Roche Molecular Systems Inc | NQX | |
| Z-0270-2018 | Class II | L3 Security & Detection System Cabinet X-ray system used for security screening of... | L3 Security & Detection | RCG | |
| Z-0187-2018 | Class I | LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The... | Physio Control, Inc. | MKJ | |
| Z-0186-2018 | Class I | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The... | Physio Control, Inc. | MKJ | |
| Z-1287-2018 | Class II | Arterial Access Tray, introducer catheter; Model: GU-04020 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-1286-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04220 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-1285-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04122 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-1284-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04120 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-1283-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04020-C | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-1282-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04020 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-1281-2018 | Class II | Radial Artery Catheterization Kit; Model: AK-04018 | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-0525-2018 | Class II | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10... | ConvaTec Limited | PQE | |
| Z-1306-2018 | Class II | A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number... | Zimmer GmbH | HRS | |
| Z-1069-2018 | Class II | STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination... | Diagnostica Stago, Inc. | GJS | |
| Z-1068-2018 | Class II | STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of... | Diagnostica Stago, Inc. | GJS | |
| Z-1067-2018 | Class II | Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of... | Diagnostica Stago, Inc. | GJS | |
| Z-1066-2018 | Class II | Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of... | Diagnostica Stago, Inc. | GJS | |
| Z-1009-2018 | Class II | fastener, fixation, nondegradable, soft tissue | Zimmer GmbH | MBI | |
| Z-1240-2018 | Class II | Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery | Zimmer GmbH | LXH | |
| Z-0936-2018 | Class II | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube... | Medtronic, Inc. | GAZ | |
| Z-2732-2018 | Class II | rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF | |
| Z-2731-2018 | Class II | radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF | |
| Z-2730-2018 | Class II | rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF |