The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

15951–15975 of 39988

  • HighFDA (Devices)·Z-0234-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Sets Due to Seal Defect

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

    Product
    47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01)10887709121154(17)250101(30)25(10)4573639. The Intravascular Administration Set is a single…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2021·2020-10-28

    ICU Medical Recalls Smallbore Pressure Infusion Extension Sets Due to Seal Defect

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

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case.…
    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-0170-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors for Seal Issues

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2021·2020-10-28

    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
    10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709083346(17)250201(30)50(10)4718652. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2021·2020-10-28

    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
    13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968. The Intravascular Administration Set is a single use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2021·2020-10-28

    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
    7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)50(10)4558614; (01)10887709067582(17)250201(30)50(10)4733732…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly curved absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2021·2020-10-28

    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
    11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2021·2020-10-28

    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 from sealing properly.

    Product
    60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2021·2020-10-28

    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
    11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(17)250101(30)50(10)4558624. The Intravascular Administration Set is a single use, sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX 5.0MM AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Packaging Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete pouch seals may breach the sterile barrier.

    Product
    HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2021·2020-10-28

    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
    10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(17)250201(30)50(10)4713953; (01)10887709067322(17)250201(30)50(10)4730099…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2021·2020-10-28

    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 the NanoClave spike from sealing properly.

    Product
    9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2021·2020-10-28

    Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.

    Product
    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect

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

    Product
    165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for…
    Category
    Medical Device
    Distribution
    Distributed nationwide