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.

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16226–16250 of 40287

  • HighFDA (Devices)·Z-0157-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

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

    Product
    TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect

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

    Product
    20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874; (01)10840619092754(17)250101(30)50(10)4565685 Administration sets and their accessories are single use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2021·2020-10-28

    ICU Medical NanoClave Stopcock Manifold Recalled for Manufacturing Defect

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

    Product
    Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2021·2020-10-28

    ICU Medical Recalls 128-inch Primary Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 128-inch primary sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709011691(17)250201(30)50(10)4711125;(01)10887709011691(17)250201(30)50(10)4718711. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2021·2020-10-28

    ICU Medical Recalls 139-inch Admin Sets Due to Potential Seal Defect

    ICU Medical is recalling specific lots of 139-inch intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101(30)25(10)4556713; (01)10887709121147(17)250101(30)25(10)4603383…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2021·2020-10-28

    Smith & Nephew Recalls Absorbable Suture Anchors Due to Seal Defects

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

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

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

    Product
    112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2021·2020-10-28

    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 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2021·2020-10-28

    Ethicon Recalls VICRYL Sutures Due to Packaging Mismatch

    Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.

    Product
    VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0124-2021·2020-10-28

    Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors

    Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.

    Product
    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

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

    Product
    TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2021·2020-10-28

    Sobel Westex Disposable Isolation Gowns Recalled for Performance Failures

    Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.

    Product
    SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2021·2020-10-28

    Smith & Nephew Recalls Healicoil Absorbable Suture Anchors for Seal Defects

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

    Product
    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0141-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Defects

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

    Product
    TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

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

    Product
    TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2021·2020-10-28

    Encore Medical Recalls Mislabeled AltiVate Shoulder Socket Inserts

    Encore Medical is recalling 15 AltiVate Reverse Small Socket Inserts due to mislabeling. The error may cause surgery delays or the need for revision surgery.

    Product
    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

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

    Product
    8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17)250101(30)50(10)4572784. The Intravascular Administration Set is a single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2021·2020-10-28

    Fujifilm Synapse PACS Software Version 5.6.1 Recalled for CT Measurement Error

    Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.

    Product
    Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2021·2020-10-28

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

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

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2021·2020-10-28

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

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

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Issues

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

    Product
    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0160-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors

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

    Product
    TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0151-2021·2020-10-28

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

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

    Product
    OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
    Category
    Medical Device
    Distribution
    Distributed nationwide