The Recall Desk

Hazard

Seal Defect recalls

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

What the numbers show

Total
117
Critical
1
Severe
4
Most recent
2026-08-12

Of the 117 seal defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (3%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all seal defect 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.

51–75 of 117

  • HighFDA (Devices)·Z-0247-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.

    Product
    7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)250201(30)50(10)4724881. The Intravascular Administration Set is a single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0223-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

    Product
    26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0266-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent the spike from sealing properly.

    Product
    8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(30)50(10)4558474. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2021·2020-10-28

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241101(30)50(10)4475297; (01)10887709032153(17)250201(30)50(10)4711598. The I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2021·2020-10-28

    ICU Medical Recalls NanoClave Sets Due to Potential Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit a proper seal.

    Product
    142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393(17)250101(30)25(10)4603380; (01)10887709089393(17)250101(30)25(10)4711169; (01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 6-inch Intravascular Administration Sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)50(10)4559022. The Intravascular Administration Set is a single use, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0253-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave Intravascular Administration Sets due to a manufacturing defect that may prevent a proper seal.

    Product
    60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2021·2020-10-28

    ICU Medical Recalls NanoClave Stopcock Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave stopcock sets due to a manufacturing defect that may prevent a proper seal.

    Product
    Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)4549131. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2021·2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265; (01)10887709087526(17)250201(30)50(10)4724859; (01)10887709087526(17)250201(30)50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(17)250201(30)25(10)4719610. . The Intravascular Administration Set is a singl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2021·2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709066417(17)250101(30)50(10)45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2021·2020-10-28

    ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect

    ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619; (01)10887709070551(17)250101(30)50(10)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2021·2020-10-28

    ICU Medical Recalls NanoClave High Pressure Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave high pressure extension sets because a manufacturing defect may prevent a proper seal.

    Product
    7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071527(17)250101(30)50(10)4603281. The high pressure extension set is a device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets due to a manufacturing defect that may prevent a proper seal.

    Product
    11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their acc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

    Product
    226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201(30)50(10)4734990. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

    Product
    60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the admi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2021·2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore bifuse extension sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

    Product
    5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262. The Intravascular Administration Set is a single use, sterile, non-pyrogenic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a si
    Category
    Medical Device
    Distribution
    Distributed nationwide