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-1978-2011 | UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1977-2011 | UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1736-2011 | Access Total BhCG (BhCG) Assay Part Number 33500 The Access Total BhCG assay is a... | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-0812-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile... | Boston Scientific Corporation | FCG | ||
| Z-0811-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile... | Boston Scientific Corporation | FCG | ||
| Z-0810-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52... | Boston Scientific Corporation | FCG | ||
| Z-0809-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72... | Boston Scientific Corporation | FCG | ||
| Z-0968-2011 | Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589... | Terumo Cardiovascular Systems Corporation | GFA | ||
| Z-0561-2011 | Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an... | Darex Container Products Div of W.R. Grace & Co. | CBL | ||
| Z-0560-2011 | SODASORB Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl... | Darex Container Products Div of W.R. Grace & Co. | CBL | ||
| Z-0993-2011 | Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The... | Arstasis, Inc. | DYB | ||
| Z-0863-2011 | Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-0862-2011 | Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-0861-2011 | Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain... | Boston Scientific Corporation | HGC | ||
| Z-0860-2011 | Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-0859-2011 | Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain... | Boston Scientific Corporation | HGC | ||
| Z-0858-2011 | Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain... | Boston Scientific Corporation | HGC | ||
| Z-0857-2011 | Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-0856-2011 | Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain... | Boston Scientific Corporation | HGC | ||
| Z-0855-2011 | Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-1389-2011 | S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy... | Depuy Orthopaedics Inc. | LXH | ||
| Z-1388-2011 | S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy... | Depuy Orthopaedics Inc. | LXH | ||
| Z-0854-2011 | Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of... | Boston Scientific Corporation | HGC | ||
| Z-0543-2011 | Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO... | Edwards Lifesciences LLC | DTL | ||
| Z-0542-2011 | Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO... | Edwards Lifesciences LLC | DTL | ||
| Z-1475-2011 | Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all... | Integra LifeSciences Corporation | MQP | ||
| Z-0972-2011 | Bio Med Devices Disposable Pediatric Breathing Circuit, One Set Catalog Number: 4040LC 5... | Bio-Med Devices, Inc. | CBK | ||
| Z-0971-2011 | Bio Med Devices Disposable Pediatric Breathing Circuit, One Set, Catalog Number... | Bio-Med Devices, Inc. | CBK | ||
| Z-0414-2011 | Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management... | Philips North America LLC | DXJ | ||
| Z-1817-2011 | 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V... | Gentherm Medical, LLC | DWJ | ||
| Z-2215-2011 | Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to... | Siemens Healthcare Diagnostics Inc. | MSW | ||
| Z-0852-2011 | Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R... | Cook Incorporated | FAD | ||
| Z-0616-2011 | Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part... | Fresenius Kabi AB | LKN | ||
| Z-0903-2011 | PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson... | Ethicon, Inc | FTL | ||
| Z-0590-2011 | Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By... | Orthofix SRL | LWE | ||
| Z-0716-2011 | SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4... | Patterson Dental Supply, Inc. | EBF | ||
| Z-1094-2011 | Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List... | Abbott Medical | GKZ | ||
| Z-0468-2011 | CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 | TORNIER Inc. | HWX | ||
| Z-0467-2011 | CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 | TORNIER Inc. | HWX | ||
| Z-0466-2011 | CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 | TORNIER Inc. | HWX | ||
| Z-0447-2011 | Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product... | Medtronic Navigation, Inc | IZL | ||
| Z-0411-2011 | smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma... | Smith & Nephew, Inc. | OLO | ||
| Z-0398-2011 | SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8"... | Philips North America LLC | KPS | ||
| Z-0424-2011 | BARD Ventrio Small Circle Hernia Patch 3.0" Product Code: 0010213 Indicated for use in... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0423-2011 | BARD Ventrio Large Oval Hernia Patch 5.4" x 7.0" Product Code: 0010212 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0422-2011 | BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7" Product Code: 0010211 Indicated for... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0446-2011 | BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0024-2011 | Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo... | Terumo Cardiovascular Systems Corporation | KRL | ||
| Z-0797-2011 | Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and... | Canon Medical Informatics, Inc. | LLZ | ||
| Z-0538-2011 | Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the... | Elekta Limited | IYE |