The Recall Desk

Hazard

Tubing Detachment recalls

20 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
20
Critical
0
Severe
2
Most recent
2023-02-15

Of the 20 tubing detachment recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all tubing detachment recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–20 of 20

  • HighFDA (Devices)·Z-1100-2023·2023-02-15

    Precision Delivery Sets recalled due to potential tubing detachment

    Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.

    Product
    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment

    Edwards Lifesciences is recalling its pressure monitoring set due to potential tubing detachment. Approximately 460 units distributed across North America and Europe are affected.

    Product
    Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1961-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set: Potential Tubing Detachment

    Edwards Lifesciences is recalling a pressure monitoring set due to potential detachment of the pressure tubing from the blood sampling system. The recall affects 290 units distributed across multiple US states and international locations.

    Product
    Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1965-2021·2021-07-07

    Pressure monitoring set recalled for potential pressure tubing detachment

    Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.

    Product
    Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1963-2021·2021-07-07

    Edwards VAMP Jr. blood management system pressure tubing may detach

    Edwards Lifesciences is recalling 1,679 units of Edwards VAMP Jr. 6 in blood management systems (lot 63445142, 63630816) due to potential pressure tubing detachment.

    Product
    Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1964-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment

    Edwards Lifesciences is recalling 990 units of the Edwards TruWave (30 cc)/VAMP Jr Kit pressure monitoring set because the pressure tubing may detach from the blood sampling system. Healthcare facilities should discontinue use.

    Product
    Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1962-2021·2021-07-07

    Blood Management System Pressure Tubing May Detach

    Edwards Lifesciences blood management system (VJ0990) pressure tubing may detach from the blood sampling system during use. The recall affects 2,000 units distributed across the U.S., Canada, UK, and Italy.

    Product
    Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1966-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Recalled Due to Tubing Detachment Risk

    Edwards Lifesciences is recalling Edwards TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets (Lot 63545959) due to a potential risk that pressure tubing may detach from the blood sampling system.

    Product
    Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-1960-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall

    Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.

    Product
    Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2228-2017·2017-06-14

    ConvaTec Recalls Elongated Oxygen Masks Due to Tubing Detachment Risk

    ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.

    Product
    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
    Category
    Medical Device
    Distribution
    14 states
  • 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-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-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-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-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-0890-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0524-2015·2014-12-17

    Medtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk

    Medtronic MiniMed is recalling Silhouette and Sure-T infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusi
    Category
    Medical Device
    Distribution
    Distributed nationwide