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-2806-2015 | Class II | Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in... | FUJIFILM Healthcare Americas Corporation | FET | |
| Z-2805-2015 | Class II | Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. | FUJIFILM Healthcare Americas Corporation | FET | |
| Z-2778-2015 | Class II | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5... | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-2376-2015 | Class II | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer... | BIOTRONIK AG | rce | |
| Z-2544-2015 | Class II | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2351-2015 | Class II | PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a... | Remel Inc | GTY | |
| Z-2350-2015 | Class II | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination... | Remel Inc | GTY | |
| Z-0474-2016 | Class II | Enterococcus Screen Agar QUAD Plate | Becton Dickinson & Co | JWY | |
| Z-0473-2016 | Class II | Vancomycin Screen Agar | Becton Dickinson & Co | JWY | |
| Z-2342-2015 | Class II | Axiom Artis systems, dedicated angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-2341-2015 | Class II | Artis Q systems; dedicated angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0291-2016 | Class III | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated... | Baxter Healthcare Corporation | FKX | |
| Z-2340-2015 | Class II | Siemens Artis zee systems; dedicated angiography systems developed for single and biplane... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-2344-2015 | Class II | ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2352-2015 | Class II | ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for... | Merit Medical Systems, Inc. | GBQ | |
| Z-2268-2015 | Class II | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional... | Medtronic, Inc. | DQA | |
| Z-2267-2015 | Class II | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or... | Medtronic, Inc. | DQA | |
| Z-0208-2016 | Class II | e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2419-2015 | Class III | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and... | Getinge Disinfection AB | MEC | |
| Z-2279-2015 | Class II | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20... | Hardy Diagnostics | JSO | |
| Z-2278-2015 | Class II | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20... | Hardy Diagnostics | JSO | |
| Z-2277-2015 | Class II | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10... | Hardy Diagnostics | JSO | |
| Z-2276-2015 | Class II | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged... | Hardy Diagnostics | JSO | |
| Z-2275-2015 | Class II | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10... | Hardy Diagnostics | JSO | |
| Z-2061-2015 | Class II | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and... | AGFA Healthcare Corp. | LLZ | |
| Z-2274-2015 | Class II | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20... | Hardy Diagnostics | JSO | |
| Z-2273-2015 | Class II | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm... | Hardy Diagnostics | JSO | |
| Z-2095-2015 | Class II | Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i... | Abbott Diagnostics Scarborough, Inc. | OCC | |
| Z-2810-2015 | Class II | Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component | Howmedica Osteonics Corp | LPH | |
| Z-2321-2015 | Class II | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2314-2015 | Class II | ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2315-2015 | Class II | Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical... | TORNIER Inc. | HSB | |
| Z-2430-2015 | Class II | Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for... | Howmedica Osteonics Corp | KXE | |
| Z-2429-2015 | Class II | Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended... | Howmedica Osteonics Corp | JDB | |
| Z-2428-2015 | Class II | Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in... | Howmedica Osteonics Corp | JDB | |
| Z-2427-2015 | Class II | uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement... | Howmedica Osteonics Corp | KXE | |
| Z-2349-2015 | Class II | 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical... | Zimmer Surgical SA | KCY | |
| Z-2426-2015 | Class II | rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the... | Howmedica Osteonics Corp | JDB | |
| Z-2262-2015 | Class II | FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 | Encore Medical, LP | HWT | |
| Z-2148-2015 | Class II | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic... | EKOS Corporation | KRA | |
| Z-2330-2015 | Class II | S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and... | Roche Diagnostics GmbH | CHL | |
| Z-2086-2015 | Class II | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip... | Synthes (USA) Products LLC | FZO | |
| Z-2272-2015 | Class II | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix... | Synthes (USA) Products LLC | JEY | |
| Z-2348-2015 | Class II | 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc... | Zimmer Surgical SA | KCY | |
| Z-2192-2015 | Class II | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type... | Hardy Diagnostics | JSO | |
| Z-2270-2015 | Class II | Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight... | Handicare USA, Inc. | FSA | |
| Z-2269-2015 | Class II | Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient... | Handicare USA, Inc. | FSA | |
| Z-2705-2017 | Class II | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS... | O-Two Medical Technologies, Inc. | JBS | |
| Z-2434-2015 | Class III | BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a... | Becton Dickinson & Co | JKA | |
| Z-2136-2015 | Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with... | Volcano Corporation | IYO |