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-0021-06 | Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | ||
| Z-0020-06 | Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | ||
| Z-1457-05 | Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP. | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MVH | ||
| Z-0172-06 | Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the... | Siemens Healthcare Diagnostics Inc. | DAP | ||
| Z-1458-05 | Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in... | Becton Dickinson & Co | JTZ | ||
| Z-1566-05 | Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical... | Encore Medical, LP | JWH | ||
| Z-1583-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1582-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1581-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 60... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1580-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 40... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1579-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 100... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1578-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-1577-05 | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog... | Angiomed GmbH & Co. Medizintechnik KG | FGE | ||
| Z-0086-06 | Serum Blood Collection Tubes | Greiner Bio-One North America, Inc. | JKA | ||
| Z-1020-05 | Adapter for ACMI Hysteroscope Catalog Number: 55035 | Boston Scientific Corporation | MNB | ||
| Z-1538-05 | SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-1537-05 | SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, 90-degree angled... | Scanlan International Inc | DXY | ||
| Z-1536-05 | SCANLAN Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-1535-05 | SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-1534-05 | SCANLAN Premier Jacobson Micro Scissors, Spring Style, round handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-0022-06 | Interis Allura BiPlane X-Ray System | Philips North America LLC | JAK | ||
| Z-1533-05 | Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-1532-05 | Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree... | Scanlan International Inc | DXY | ||
| Z-0140-06 | Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The... | Terumo Cardiovascular Systems Corporation | KFM | ||
| Z-0301-06 | Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product... | Abbott Medical | BTO | ||
| Z-1397-05 | Alsius CoolGard 3000 Temperature Regulation System | Alsius Corp. | NCX | ||
| Z-1109-05 | CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers... | Boston Scientific Corporation | LWP | ||
| Z-1108-05 | VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and... | Boston Scientific Corporation | LWP | ||
| Z-1107-05 | VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using... | Boston Scientific Corporation | LWP | ||
| Z-0174-06 | cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and... | Haemonetics Corporation | CAC | ||
| Z-0034-06 | Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000. | Stryker Corp. | LXC | ||
| Z-1378-05 | SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR... | Cepheid | NSR | ||
| Z-1522-05 | Banana Peel™ Sheaths - 9/45 Catalog Number: 260300 | Boston Scientific Corporation | KOB | ||
| Z-1521-05 | Banana Peel™ Sheaths - 16/30 Catalog Number: 260204 | Boston Scientific Corporation | KOB | ||
| Z-1520-05 | Banana Peel™ Sheaths - 14/30 Catalog Number: 260203 | Boston Scientific Corporation | KOB | ||
| Z-1519-05 | Banana Peel™ Sheaths - 12/30 Catalog Number: 260202 | Boston Scientific Corporation | KOB | ||
| Z-1518-05 | Banana Peel™ Sheaths - 11/30 Catalog Number: 260201 | Boston Scientific Corporation | KOB | ||
| Z-1517-05 | Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1516-05 | Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1515-05 | Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1514-05 | Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1513-05 | Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1512-05 | Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1511-05 | Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1510-05 | Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1509-05 | Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1508-05 | Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1507-05 | Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV... | Boston Scientific Corporation | KOB | ||
| Z-1506-05 | Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Plastic Catalog Number: 45-559 | Boston Scientific Corporation | KOB | ||
| Z-1505-05 | Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558 | Boston Scientific Corporation | KOB |