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 deaths or serious injuries are reported, 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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2251–2275 of 27375

  • HighFDA (Devices)·Z-2526-2025·2025-09-10

    CADD 100 mL flow stop reservoirs recalled over weakened bag welds

    Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2527-2025·2025-09-10

    NRFit yellow cassette reservoirs recalled over weakened medication bag welds

    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.

    Product
    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2512-2025·2025-09-10

    CVS honey wound pads recalled over packaging failures breaching sterile barrier

    CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.

    Product
    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2025·2025-09-10

    Medication cassette reservoirs recalled over weakened bag welds causing leakage

    Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Interventional imaging systems recalled because single phase UPS may fail on power loss

    Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2025·2025-09-10

    CADD 50 mL cassette reservoirs recalled over weakened bag welds

    Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2505-2025·2025-09-10

    MediHoney paste tubes 31505 recalled over packaging failures affecting sterility

    MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2025·2025-09-10

    External fixation universal joints recalled because pins may become dislodged

    Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.

    Product
    Medshape Universal Joints, REF: DNE-9000-UJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2025·2025-09-10

    CADD yellow 100 mL reservoirs recalled over weakened medication bag welds

    Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.

    Product
    Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2496-2025·2025-09-10

    InPen app recalled over software errors affecting insulin dose reminders

    Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

    Product
    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    Radiotherapy systems recalled over software allowing more than two daily fractions

    RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2025·2025-09-10

    MediHoney HCS sheet dressings recalled over packaging failures breaching sterility

    MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2025·2025-09-10

    Azurion imaging systems recalled because single phase UPS may fail on power loss

    Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.

    Product
    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2025·2025-09-10

    MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures

    MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2025·2025-09-10

    MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures

    MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2025·2025-09-10

    Flow stop cassette reservoirs recalled because medication bag welds may weaken

    Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.

    Product
    Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2506-2025·2025-09-10

    MediHoney paste tubes recalled over packaging failures breaching the sterile barrier

    MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist envir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2025·2025-09-10

    MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures

    MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2025·2025-09-10

    Sterile cover kits recalled because elastic bands may detach during surgery

    Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.

    Product
    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2025·2025-09-10

    MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility

    MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical drape packs recalled because open seals may compromise sterility

    Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.

    Product
    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2025·2025-09-10

    Tumor profiling assay recalled after incorrect result gave wrong therapy recommendation

    One MI Cancer Seek tumor mutational profiling assay is recalled because an incorrect test result was provided that indicated the incorrect drug therapy recommendation.

    Product
    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide