FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list SPS Sterilization with 15 device recalls. The most recent is a device recall dated Mar 7, 2018: Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 7, 2018 | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
| Mar 7, 2018 | Vascular Solutions Venture Rx Catheter, 6F, resterilized.Class II · The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process use | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
