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-2487-2018 | Class II | Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm... | Medtronic, Inc. | GBX | |
| Z-2486-2018 | Class II | Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm... | Medtronic, Inc. | GBX | |
| Z-2485-2018 | Class II | Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric... | Medtronic, Inc. | GBX | |
| Z-1743-2019 | Class II | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for... | Bio-Rad Laboratories Inc. | JSO | |
| Z-1742-2019 | Class II | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is... | Bio-Rad Laboratories Inc. | JSO | |
| Z-0232-2020 | Class II | Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN... | Stryker Corp. | DQX | |
| Z-0231-2020 | Class II | Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No... | Stryker Corp. | DQX | |
| Z-0230-2020 | Class II | Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN... | Stryker Corp. | DQX | |
| Z-0229-2020 | Class II | Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No... | Stryker Corp. | DQX | |
| Z-0228-2020 | Class II | Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN... | Stryker Corp. | DQX | |
| Z-0227-2020 | Class II | Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No... | Stryker Corp. | DQX | |
| Z-0226-2020 | Class II | Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN... | Stryker Corp. | DQX | |
| Z-0225-2020 | Class II | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No... | Stryker Corp. | DQX | |
| Z-2821-2018 | Class II | ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number... | Zimmer GmbH | KWA | |
| Z-2820-2018 | Class II | ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis... | Zimmer GmbH | JDI | |
| Z-2575-2018 | Class II | Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is... | Randox Laboratories, Limited | JJY | |
| Z-2602-2018 | Class II | Zimmer Dermatone AN, Model No. 88710100 | Zimmer Surgical SA | GFD | |
| Z-2534-2018 | Class II | PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6... | Ethicon, Inc | NEW | |
| Z-2533-2018 | Class II | PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3... | Ethicon, Inc | NEW | |
| Z-2532-2018 | Class II | PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0... | Ethicon, Inc | NEW | |
| Z-0112-2019 | Class II | GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following... | GE Healthcare | LNH | |
| Z-0111-2019 | Class II | GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names... | GE Healthcare | LNH | |
| Z-0110-2019 | Class II | GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names... | GE Healthcare | LNH | |
| Z-2554-2018 | Class II | RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-3279-2018 | Class II | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following... | GE Healthcare | LNH | |
| Z-2317-2018 | Class II | Single Chamber Temporary External Pacemaker, Model 53401 | Medtronic, Inc. | DTE | |
| Z-2745-2018 | Class II | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product... | Tosoh Bioscience Inc | LCP | |
| Z-2827-2018 | Class III | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains... | Tosoh Bioscience Inc | JIX | |
| Z-3020-2018 | Class II | Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090... | Stryker Corp. | NJE | |
| Z-0093-2019 | Class II | NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr... | Halyard Health | FPD | |
| Z-0249-2020 | Class II | EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An... | Intuitive Surgical, Inc. | NAY | |
| Z-2749-2018 | Class III | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown... | Richard-Allan Scientific LLC | IFB | |
| Z-2469-2018 | Class II | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to... | Fx Shoulder Solutions SAS | HSD | |
| Z-2468-2018 | Class II | Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to... | Fx Shoulder Solutions SAS | HSD | |
| Z-2556-2018 | Class II | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for... | Artivion, Inc. | MUQ | |
| Z-2343-2018 | Class II | 26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550 | B Braun Medical Inc | NEP | |
| Z-2555-2018 | Class II | Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with... | Leica Microsystems, Inc. | EPT | |
| Z-0226-2019 | Class II | Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi... | Nakanishi Inc. | KMW | |
| Z-0225-2019 | Class II | Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi... | Nakanishi Inc. | KMW | |
| Z-0224-2019 | Class II | Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi... | Nakanishi Inc. | KMW | |
| Z-0223-2019 | Class II | Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi... | Nakanishi Inc. | KMW | |
| Z-0222-2019 | Class II | Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA... | Nakanishi Inc. | KMW | |
| Z-0221-2019 | Class II | Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA... | Nakanishi Inc. | KMW | |
| Z-0220-2019 | Class II | Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA... | Nakanishi Inc. | KMW | |
| Z-0219-2019 | Class II | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical... | Nakanishi Inc. | KMW | |
| Z-3251-2018 | Class II | Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2... | Medtronic Navigation, Inc | LLZ | |
| Z-2791-2018 | Class II | VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product... | Cook Incorporated | NHC | |
| Z-2931-2018 | Class II | N Latex CDT Kit | CSL Behring LLC | NAO | |
| Z-0199-2019 | Class II | Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic... | Canon Medical Systems USA, Inc. | LNH | |
| Z-2957-2018 | Class II | FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR... | Baxter Healthcare Corporation | PMX |