The Recall Desk

Manufacturer

Unomedical As

7 recalls in our database name Unomedical As as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2016-11-09

Of the 7 recalls from Unomedical As we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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.

1–7 of 7

  • SevereFDA (Devices)·Z-0357-2017·2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    Product
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination wit
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0358-2017·2016-11-09

    Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment

    Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.

    Product
    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0360-2017·2016-11-09

    Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk

    Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 units distributed in the US and internationally.

    Product
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0355-2017·2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 4
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0356-2017·2016-11-09

    Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk

    Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0359-2017·2016-11-09

    Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units distributed in the US and internationally.

    Product
    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1821-2015·2015-07-01

    Unomedical Infusion Set Needles Recalled for Potential Breakage During Use

    Unomedical is recalling specific infusion sets because the steel needle can break during use, interrupting medication delivery.

    Product
    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
    Category
    Medical Device
    Distribution
    4 states