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-0031-2011 | SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M | Zimmer GmbH | KWP | ||
| Z-0030-2011 | SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S | Zimmer GmbH | KWP | ||
| Z-0029-2011 | SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL | Zimmer GmbH | KWP | ||
| Z-0028-2011 | SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L | Zimmer GmbH | KWP | ||
| Z-0027-2011 | SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M | Zimmer GmbH | KWP | ||
| Z-0026-2011 | SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S | Zimmer GmbH | KWP | ||
| Z-1438-2011 | Mycobacterium Tuberculosis Complex Culture Identification Test, 2860. | Hologic, Inc. | LQF | ||
| Z-1437-2011 | Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835. | Hologic, Inc. | LQF | ||
| Z-1436-2011 | Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820. | Hologic, Inc. | MDK | ||
| Z-0914-2009 | Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with... | Boston Scientific Corporation | KNT | ||
| Z-0913-2009 | Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free... | Boston Scientific Corporation | KNT | ||
| Z-0912-2009 | Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile... | Boston Scientific Corporation | KNT | ||
| Z-0911-2009 | Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile... | Boston Scientific Corporation | KNT | ||
| Z-0623-2009 | Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version... | Philips North America LLC | KPR | ||
| Z-0185-2012 | The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery... | Physio Control, Inc. | LDD | ||
| Z-1938-2009 | Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil... | Quality Electrodynamics | MOS | ||
| Z-1198-2010 | Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by... | Stryker Corp. | HIF | ||
| Z-0948-2009 | iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and... | Philips North America LLC | LLZ | ||
| Z-1883-2009 | Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San... | CareFusion 303, Inc | BRY | ||
| Z-1072-2009 | Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600... | Boston Scientific Corporation | DYB | ||
| Z-1071-2009 | Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M00456... | Boston Scientific Corporation | DYB | ||
| Z-0945-2009 | IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1... | AGFA Healthcare Corp. | LLZ | ||
| Z-0979-2009 | Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical... | Boston Scientific Corporation | KNS | ||
| Z-0978-2009 | Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only... | Boston Scientific Corporation | KNS | ||
| Z-0977-2009 | Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical... | Boston Scientific Corporation | KNS | ||
| Z-1019-2011 | PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part... | Philips North America LLC | LLZ | ||
| Z-0984-2009 | DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-0983-2009 | DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-0982-2009 | DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1469-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 80mm, Product Number: ZBM14080. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1468-2009 | Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1467-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1466-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1465-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1464-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1463-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1462-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1461-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 60mm, Product Number: ZBM06060. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1460-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1459-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1458-2009 | Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1457-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1456-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1455-2009 | Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1454-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040. | Bard Peripheral Vascular Inc | FGE | ||
| Z-1453-2009 | Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. | Bard Peripheral Vascular Inc | FGE | ||
| Z-0981-2009 | DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN... | Depuy Orthopaedics Inc. | HRS | ||
| Z-1256-2009 | HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense... | Hemosense, Inc. | GJS | ||
| Z-1326-2009 | Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers... | Abbott Medical | CCK | ||
| Z-1117-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm... | Bard Access Systems, Inc. | KNT |