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-0547-04 | Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation... | Teleflex Medical | FZP | ||
| Z-0553-04 | Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have... | Moving Solutions, Inc. | FSA | ||
| Z-0552-04 | Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have electric... | Moving Solutions, Inc. | FSA | ||
| Z-0551-04 | Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have electric... | Moving Solutions, Inc. | FSA | ||
| Z-0561-04 | Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | ||
| Z-0540-04 | Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials... | Coherent, Inc. | L22 | ||
| Z-0544-04 | Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703... | DeRoyal Industries, Inc. | NAC | ||
| Z-0530-04 | CryoValve, Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0529-04 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0528-04 | Synergraft CryoValve, Aortic Valve & Conduit SG | Artivion, Inc. | MIE | ||
| Z-0527-04 | CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with... | Gvi Technology Partners | IYX | ||
| Z-1382-04 | P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code... | Depuy Orthopaedics Inc. | JWH | ||
| Z-0725-04 | VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic... | bioMerieux, Inc. | LON | ||
| Z-0536-04 | Four Shooter Saeed Multi-Band Ligator | Wilson-Cook Medical Inc. | FHN | ||
| Z-0149-04 | Lorad MIV Platinum Mammograpgy System | Hologic, Inc. | IZH | ||
| Z-0148-04 | Lorad M-IV Mammography System | Hologic, Inc. | IZH | ||
| Z-0559-04 | 4mm Hex Driver | U&I America | MNI | ||
| Z-0558-04 | 2.5mm Hex Driver | U&I America | MNI | ||
| Z-0523-04 | Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic... | Medtronic, Inc. | DQO | ||
| Z-0909-04 | This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The... | Cordis US Corp. | FGE | ||
| Z-1145-04 | Taperlock Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1144-04 | Swissplus Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1143-04 | Swedevent Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1142-04 | Screwvent Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1141-04 | Microvent Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1140-04 | Biovent Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-1139-04 | Advent Implant Line | ZimVie US Corp LLC | DZE | ||
| Z-0560-04 | Crossfire Acetabular II Insert. Catalog No: 2041C-2642. | Howmedica Osteonics Corp | JDL | ||
| Z-0359-04 | Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp | Draeger, Inc. | FTD | ||
| Z-0358-04 | Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp | Draeger, Inc. | FTD | ||
| Z-0515-04 | Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000 | Revvity Health Sciences, Inc. | JIA | ||
| Z-0514-04 | Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000 | Revvity Health Sciences, Inc. | JIA | ||
| Z-0382-04 | Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number... | Medtronic, Inc. | NAD | ||
| Z-0381-04 | Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730 | Medtronic, Inc. | NAD | ||
| Z-0380-04 | Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product... | Medtronic, Inc. | NAD | ||
| Z-0585-04 | Cruciform Slit Valve | Phoenix Biomedical Corp. | JXG | ||
| Z-0378-04 | MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer... | Staar Surgical AG | KYB | ||
| Z-0885-04 | EZ-DOP, diagnostic ultrasound imaging system | DWL Systems, Inc. | IYN | ||
| Z-0294-2007 | Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0542-04 | Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338 | Hardy Diagnostics | JTO | ||
| Z-0538-04 | Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part #... | Welch Allyn Protocol, Inc. | DSI | ||
| Z-0089-2011 | SoftPath GUI Versions 3.17 and 4.1. SCC Soft Computer 5400 Tech Data Drive, Clearwater... | SCC Soft Computer | LNX | ||
| Z-0638-04 | HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product... | Datascope Corp. | DSY | ||
| Z-0571-04 | Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model... | Howmedica Osteonics Corp | LZO | ||
| Z-0354-04 | Sure Temp Plus Model 690/692 Oral Temperature Probes | Welch Allyn Inc | FLL | ||
| Z-0352-04 | Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8 | Toray International America Inc. | FJI | ||
| Z-0351-04 | Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU | Toray International America Inc. | FJI | ||
| Z-0350-04 | Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a | Toray International America Inc. | FJI | ||
| Z-0349-04 | Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H | Toray International America Inc. | FJI | ||
| Z-0304-04 | Stryker brand Synergy extended stay stretcher; model 1050 | Stryker Medical | INK |