The Recall Desk

Manufacturer

SPS Sterilization, Inc

15 recalls in our database name SPS Sterilization, Inc as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2018-09-19

Of the 15 recalls from SPS Sterilization, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • ModerateFDA (Devices)·Z-3036-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents

    SPS Sterilization is recalling two Boston Scientific Wallstent tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life of the sterilization process.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3035-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error

    SPS Sterilization is recalling two Boston Scientific Wallstent devices because the expiration date on the label exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3038-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis

    SPS Sterilization, Inc. is recalling two units of resterilized Boston Scientific Wallstent Enteral Endoprosthesis because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3040-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error

    SPS Sterilization, Inc. is recalling three Boston Scientific Wallstent RP Endoprosthesis tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3032-2018·2018-09-19

    SPS Sterilization Recalls Edwards Femoral Venous Cannula Due to Shelf Life Error

    SPS Sterilization is recalling one unit of an Edwards Lifesciences Femoral Venous Cannula because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3037-2018·2018-09-19

    Recall of Boston Scientific Tracheobronchial Stents Due to Sterilization Labeling Error

    SPS Sterilization, Inc. is recalling two Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stents because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3028-2018·2018-09-19

    SPS Sterilization Recalls Edwards Lifesciences Aortic Cannula Due to Labeling Error

    SPS Sterilization is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3039-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Boston Scientific Wallstent RP Endoprosthesis

    SPS Sterilization is recalling two units of resterilized Boston Scientific Wallstent RP Endoprosthesis because the labeling expiration date exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3031-2018·2018-09-19

    SPS Sterilization Recalls Avid Venous Drainage Cannulas Due to Shelf Life Labeling

    SPS Sterilization is recalling 5 units of Avid Dual Stage Venous Drainage Cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3030-2018·2018-09-19

    SPS Sterilization Recalls Edwards Venous Drainage Cannulas Due to Labeling Error

    SPS Sterilization is recalling five units of Edwards Lifesciences venous drainage cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3034-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Edwards Arterial Perfusion Cannula

    SPS Sterilization is recalling one resterilized Edwards Lifesciences Optisite Arterial Perfusion Cannula because its expiration date exceeds the validated shelf life.

    Product
    Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states