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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9501–9525 of 27393

  • HighFDA (Devices)·Z-1545-2022·2022-08-24

    Simply Saline Nasal Mist Recalled for Improper Storage Conditions

    Simply Saline Nasal Mist 3.1 oz sold at Family Dollar stores has been recalled due to improper temperature storage between May and June 2022. Consumers should return the product to their local Family Dollar store.

    Product
    SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2022·2022-08-24

    Dressing Change Kit Mislabeled as Latex-Free Contains Natural Rubber Latex

    Trinity Sterile's Wolf Pak Premium Dressing Change Kit is mislabeled as latex-free but contains natural rubber latex in component 94-7002. This poses a risk to people with latex allergies.

    Product
    Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2022·2022-08-24

    Surgical forceps recalled due to potentially compromised sterile barrier

    Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2022·2022-08-24

    Abbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration

    Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.

    Product
    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1523-2022·2022-08-24

    Power Electronic Box Subassembly Loose Screws Pose Electrical Shock Risk

    Myolyn Inc. is recalling the power electronic box subassembly for the MyoCycle MC-2 because internal mounting screws may come loose during shipping, creating a risk of electrical shock.

    Product
    Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1548-2022·2022-08-24

    Medical dressing tray mislabeled as latex-free but contains natural rubber latex

    Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.

    Product
    Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2022·2022-08-24

    Pregnancy Test Units Recalled Due to Improper Temperature Storage

    Clearblue Smart Countdown pregnancy tests distributed to Family Dollar stores were not stored in temperature-controlled conditions. Consumers who purchased this product should return it for a refund or replacement.

    Product
    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2022·2022-08-24

    FDA Recalls Echelon-14 Microcatheters Due to Moisture-Exposed Packaging

    Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.

    Product
    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2022·2022-08-24

    CURAD First Aid Kit Recalls Due to Improper Storage Temperature

    Family Dollar is recalling CURAD First Aid Kits (SKU 999037) that were improperly stored without temperature control from April 30 to June 10, 2022. The temperature exposure may have degraded medications or compromised medical devices within the kits.

    Product
    CURAD FIRST AID KIT, SKU 999037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2022·2022-08-24

    Contact Lens Multi-Purpose Solution Recalled for Improper Storage

    Family Dollar is recalling BIOTRU Multi-Purpose Solution (4 oz, SKU 999009) due to improper temperature-controlled storage. Approximately 1,051 units were affected across US Family Dollar stores.

    Product
    B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2022·2022-08-24

    Sterile Surgical Pads and Wound Care Kits Recalled Due to Structural Failure

    ASO LLC is recalling 274,458 retail packages of three wound care products that fall apart during handling after removal from packaging, compromising their sterility and usability.

    Product
    (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2022·2022-08-24

    BD PhaSeal Y-Site Connector recalled for mislabeled expiration dates

    Becton Dickinson recalls 9,340 units of BD PhaSeal Y-Site Connectors (Catalog 515304) due to incorrect expiration dates printed on product labels that extend beyond the actual product expiration.

    Product
    BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 51530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2022·2022-08-24

    LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT Recalled Due to Improper Temperature Storage

    Family Dollar is recalling LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT that were stored without proper temperature control. Customers should discontinue use of product purchased between May 1 and June 10, 2022.

    Product
    LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2022·2022-08-24

    SKYN Non-Latex Condoms Recalled Due to Improper Storage

    Family Dollar is recalling SKYN Original, Elite, and LS non-latex condoms due to improper storage. Products sold between May 1 and June 10, 2022 were not stored in temperature-controlled conditions.

    Product
    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2022·2022-08-24

    ARIES SARS-CoV-2 Assay may produce false negative diagnostic results

    Luminex Corporation recalled 257 units of the ARIES SARS-CoV-2 Assay (lot AB4042A) due to potential false negative results. The assay may fail to detect the ORF1ab gene, risking missed COVID-19 infections.

    Product
    ARIES SARS-CoV-2 Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2022·2022-08-24

    Skin liquid bandage recalled for improper temperature storage

    Family Dollar's NEW SKIN Liquid Bandage was not stored in temperature-controlled conditions, potentially compromising product integrity. Affected units were sold nationwide during May through June 2022.

    Product
    NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2022·2022-08-24

    Dressing Change Kit Recalled for Latex Mislabeling Risk

    Trinity Sterile is recalling Wolf Pak Premium Dressing Change Kits labeled as latex-free. The Non-Adherent Dressing component contains natural rubber latex, creating risk for patients with latex allergies.

    Product
    Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2022·2022-08-24

    Surgical forceps recalled due to compromised sterile barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2022·2022-08-24

    GS Saline Solution recalled due to improper temperature storage

    GS Saline Solution (12 fl oz) was not stored in temperature-controlled areas, risking contamination. The affected product was sold at Family Dollar stores nationwide from May 1–June 10, 2022.

    Product
    GS SALINE SOLUTION 12FL OZ, SKU 902274
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2022·2022-08-24

    Medical Dressing Kit Recalled for Mislabeled Latex Content

    Wolf-Pak Premium Dressing Kits labeled latex-free are being recalled because a component contains natural rubber latex, posing a risk to people with latex allergies.

    Product
    Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2022·2022-08-24

    Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport

    Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.

    Product
    Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2022·2022-08-24

    Veriquick Pregnancy Test 2CT Recalled for Improper Storage

    Family Dollar is recalling Veriquick Pregnancy Test 2CT kits (SKU 903756) sold from May 1 to June 10, 2022 due to improper storage outside temperature-controlled areas.

    Product
    Veriquick Pregnancy Test 2CT, SKU 903756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1485-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

    Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy

    Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.

    Product
    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
    Category
    Medical Device
    Distribution
    0 states