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-0717-06 | NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous) | Respironics, Inc. | CBK | ||
| Z-2709-2014 | Class II | Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit... | Philips North America LLC | JAK | |
| Z-0516-06 | Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02 | Abbott Medical | JIX | ||
| Z-0716-06 | ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle... | Blackstone Medical, Inc. | KWQ | ||
| Z-0762-06 | Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0761-06 | Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0760-06 | Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0540-06 | Holt Probe Round Straight | Medtronic Sofamor Danek Instrument Manufacturing | HXX | ||
| Z-0526-06 | Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0525-06 | Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0524-06 | Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0472-06 | Uritek TC-101Urine Analyzer, catalog number TC-101 | Teco Diagnostics | KQO | ||
| Z-0681-06 | Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation... | Baxter Healthcare Renal Div | KOC | ||
| Z-0680-06 | Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation... | Baxter Healthcare Renal Div | KDI | ||
| Z-0823-06 | Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP | Haemonetics Corporation | CAC | ||
| Z-0822-06 | Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E | Haemonetics Corporation | CAC | ||
| Z-0513-06 | ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles... | Abbott Medical | MMI | ||
| Z-0471-06 | Agfa Cronex 10T Radiographic film | AGFA Healthcare Corp. | JAC | ||
| Z-0580-06 | Praxair Grab ''n Go Vantage unit, model PRX-9496. | Praxair Distribution, Inc. | CAN | ||
| Z-0579-06 | Praxair Grab ''n Go Vantage unit, model PRX-9495. | Praxair Distribution, Inc. | CAN | ||
| Z-0679-06 | Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a... | Baxter Healthcare Renal Div | KDI | ||
| Z-0553-06 | Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare... | Baxter Healthcare Corporation | MEA | ||
| Z-0552-06 | AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R... | Baxter Healthcare Corporation | MEA | ||
| Z-0551-06 | Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and... | Baxter Healthcare Corporation | MEA | ||
| Z-2007-2008 | 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica... | Howmedica Osteonics Corp | HWC | ||
| Z-0544-06 | Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC | Bard Access Systems, Inc. | LJS | ||
| Z-0543-06 | Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC. | Bard Access Systems, Inc. | LJS | ||
| Z-0542-06 | Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc. | Bard Access Systems, Inc. | LJS | ||
| Z-0541-06 | Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc. | Bard Access Systems, Inc. | LJS | ||
| Z-0179-2007 | ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec... | Linvatec Corporation | KFK | ||
| Z-0511-06 | Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr... | Boston Scientific Corporation | FFL | ||
| Z-0510-06 | Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr... | Boston Scientific Corporation | FFL | ||
| Z-0399-06 | ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System... | Philips North America LLC | LLZ | ||
| Z-0697-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0696-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0695-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0694-06 | Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0927-06 | Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is... | Exactech, Inc. | JWH | ||
| Z-0527-06 | CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer | Abbott Medical | GKZ | ||
| Z-0470-06 | Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of... | Chembio Diagnostic Systems, Inc. | GHM | ||
| Z-0378-06 | Gem Premier 3000 | Instrumentation Laboratory Co. | CGA | ||
| Z-0396-06 | Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D... | Abbott Medical | JOH | ||
| Z-0395-06 | Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube... | Abbott Medical | JOH | ||
| Z-0394-06 | Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D... | Abbott Medical | JOH | ||
| Z-0475-06 | COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R... | Siemens Healthcare Diagnostics Inc. | GKJ | ||
| Z-0474-06 | COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0657-06 | Baxter Minivolume Extension Set, product code JC9944; An Rx sterile, nonpyrogenic fluid... | Baxter Healthcare Corporation | FPA | ||
| Z-0656-06 | Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with... | Baxter Healthcare Corporation | FMG | ||
| Z-0655-06 | Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension... | Baxter Healthcare Corporation | FMG | ||
| Z-0654-06 | Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with... | Baxter Healthcare Corporation | FMG |