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-1374-2018 | Class II | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT... | TORNIER Inc. | NWJ | |
| Z-0900-2018 | Class II | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO... | Medtronic Perfusion Systems | DWJ | |
| Z-2528-2018 | Class II | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative... | Medela AG | OMP | |
| Z-1429-2018 | Class II | Halyard Closed Suction System for Adults, Multi-AccessPortClosedSuctionSystemforAdults... | Halyard Health | BSY | |
| Z-1428-2018 | Class II | Halyard Closed Suction System for Adults, Turbo- cleaningClosedSuctionSystemforAdults,Doub... | Halyard Health | BSY | |
| Z-1388-2018 | Class II | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Life Technologies Corporation | GHQ | |
| Z-1349-2018 | Class II | VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref... | Getinge US Sales LLC | FSY | |
| Z-0640-2019 | Class II | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is... | Advanced Instruments, LLC | GKL | |
| Z-1427-2018 | Class II | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate... | Halyard Health | BSY | |
| Z-0978-2018 | Class III | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a... | Philips North America LLC | MKJ | |
| Z-1197-2018 | Class II | AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL... | Zimmer GmbH | HSB | |
| Z-1196-2018 | Class II | AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB... | Zimmer GmbH | HSB | |
| Z-0806-2018 | Class II | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code... | Baxter Healthcare Corporation | KYZ | |
| Z-1744-2018 | Class II | ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay... | Hyphen Biomed Sasu | LCO | |
| Z-1743-2018 | Class II | ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of... | Hyphen Biomed Sasu | LCO | |
| Z-1742-2018 | Class II | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay... | Hyphen Biomed Sasu | LCO | |
| Z-1347-2018 | Class II | 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp, Rotating... | Abbott Medical | FMG | |
| Z-1346-2018 | Class II | 5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50... | Abbott Medical | FMG | |
| Z-1345-2018 | Class II | 7" Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches... | Abbott Medical | FMG | |
| Z-1344-2018 | Class II | 7" Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case... | Abbott Medical | FMG | |
| Z-1343-2018 | Class II | 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector... | Abbott Medical | FMG | |
| Z-1342-2018 | Class II | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp... | Abbott Medical | FMG | |
| Z-1336-2019 | Class II | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient... | Summit Medical, LLC | MUU | |
| Z-1335-2019 | Class II | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The... | Summit Medical, LLC | MUU | |
| Z-1334-2019 | Class II | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient... | Summit Medical, LLC | MUU | |
| Z-1333-2019 | Class II | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient... | Summit Medical, LLC | MUU | |
| Z-1332-2019 | Class II | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use... | Summit Medical, LLC | MUU | |
| Z-1331-2019 | Class II | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use... | Summit Medical, LLC | MUU | |
| Z-1330-2019 | Class II | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use... | Summit Medical, LLC | MUU | |
| Z-2742-2018 | Class II | 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body. | Merit Medical Systems, Inc. | FMF | |
| Z-2425-2018 | Class II | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for... | Agilent Technologies, Inc. | PLS | |
| Z-0777-2018 | Class II | 3M Surgical Clipper Professional 9681 | 3M Company | LWK | |
| Z-0920-2018 | Class II | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral... | Signature Orthopaedics Pty Limited | MEH | |
| Z-0689-2018 | Class II | Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) | Philips Consumer Lifestyle B.V. | FLL | |
| Z-2948-2018 | Class II | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for... | MEDLINE INDUSTRIES, LP - Northfield | NGT | |
| Z-2568-2018 | Class II | Nicolet Ambulatory EEG | Medtronic, Inc. | OLV | |
| Z-2478-2018 | Class II | SOMATOM Spirit(Model 10045692 ) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2477-2018 | Class II | SOMATOM Scope Power (Model 10967888) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2476-2018 | Class II | SOMATOM Scope ( Model 10967666) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2475-2018 | Class II | SOMATOM Perspective 16 (Model 10891666) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2474-2018 | Class II | SOMATOM Perspective (Model 10495568) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2473-2018 | Class II | SOMATOM Emotion 16 (10165977) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2472-2018 | Class II | SOMATOM Emotion 6 (Model 10165888) | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1105-2018 | Class II | smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY... | Smith & Nephew, Inc. | KRO | |
| Z-1596-2018 | Class II | StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500... | Cook Incorporated | FFK | |
| Z-1595-2018 | Class II | StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034 | Cook Incorporated | FFK | |
| Z-1594-2018 | Class II | StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI... | Cook Incorporated | FFK | |
| Z-1593-2018 | Class II | StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013 | Cook Incorporated | FFK | |
| Z-1592-2018 | Class II | StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006 | Cook Incorporated | FFK | |
| Z-1591-2018 | Class II | StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993 | Cook Incorporated | FFK |