The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16151–16175 of 53092

  • HighFDA (Devices)·Z-1594-2022·2022-08-31

    Medical Device Recall: Wetfield Eraser Bipolar Hemostatic due to temperature exposure

    McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.

    Product
    Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1457-2022·2022-08-31

    Mucinex FastMax Caplets Cold Flu Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Mucinex FastMax Caplets Cold Flu 4CT (SKU 903372) distributed nationwide from April to June 2022 due to improper storage temperature conditions.

    Product
    MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1563-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for potential hard plastic pieces

    Enjoy Life Natural Brands is recalling Soft Baked Chocolate Chip Cookies nationwide due to potential hard plastic contamination. Affected products have Best By dates from February to March 2023.

    Product
    Enjoy Life Soft Baked Cookies Chocolate Chip, 6 oz. (170g) UPC 853522000191
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2022·2022-08-31

    Medical device recall for temperature exposure during storage

    McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.

    Product
    a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps Recalled for Compromised Sterile Barrier

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failure that could compromise the sterile barrier. The recall affects 602,340 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2022·2022-08-31

    Mckesson Ultracell Eye Pledgets Recalled Over Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.

    Product
    Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1564-2022·2022-08-31

    Enjoy Life Soft Baked Cookies Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Soft Baked Cookies Double Chocolate Brownie due to potential hard plastic contamination. Consumers should not eat the affected product.

    Product
    Enjoy Life Soft Baked Cookies Double Chocolate Brownie, 6 oz (170g) UPC 853522000214
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1455-2022·2022-08-31

    QP Sudfedrine PE Max Strength tablets recalled for improper storage

    Family Dollar Stores is recalling QP Sudfedrine PE Max Strength tablets nationwide due to storage temperature deviations that may have compromised product quality.

    Product
    QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2022·2022-08-31

    FDA Recalls Exacta-Mix 2400 Compounding System for Potential Valve Leaks

    Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.

    Product
    The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2022·2022-08-31

    Chest Drain System Atrium 2100 mL recalled due to temperature exposure

    The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.

    Product
    GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for potential hard plastic contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies Sunseed Butter Chocolate Chip due to potential hard plastic pieces in the product. The recall affects approximately 89,736 cases distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Cookies Sunseed Butter Chocolate Chip, 6 oz. UPC 819597013801
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2022·2022-08-31

    Medical disinfectant recalled due to temperature exposure during storage

    McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.

    Product
    a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1569-2022·2022-08-31

    Enjoy Life Breakfast Ovals Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Soft Baked Fruit & Oat Breakfast Ovals (Apple Cinnamon) due to potential hard plastic pieces in the product. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals - Apple Cinnamon, 8.8 oz. UPC 819597012569
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1364-2022·2022-08-31

    AMBI Skin Cream Recalled Due to Improper Storage Conditions

    AMBI Skin Cream for normal and oily skin was recalled due to storage temperature deviations. Products were distributed to Family Dollar Stores between April and June 2022.

    Product
    AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1462-2022·2022-08-31

    Vicks DayQuil NyQuil Combination Pack Recalled for Storage Temperature

    Family Dollar Stores is recalling Vicks DayQuil/NyQuil Liquid combination packs (SKU 903367) distributed from April 30 to June 10, 2022, due to improper storage temperatures that may affect medication effectiveness.

    Product
    VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1442-2022·2022-08-31

    Mylicon Infant Gas Drops Recalled Due to Temperature Storage Deviation

    Family Dollar Stores is recalling Mylicon Infant Gas Drops 0.5 oz distributed nationwide from April 30 through June 10, 2022 due to improper storage temperature conditions.

    Product
    MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1383-2022·2022-08-31

    FDA Recalls NPX Antibiotic Ointments for Improper Storage Temperature

    Family Dollar Stores is recalling three NPX antibiotic ointment products due to improper storage temperature conditions that may affect product quality. Consumers should return or discard the products.

    Product
    NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ SKU 999855 NPX TRPL ANTIBIOTIC PLS PAIN OINMNT 1 OZ SKU 901498 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2022·2022-08-31

    BD Vacutainer Urine Collection Tubes Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.

    Product
    a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V657000·2022-08-31

    2022 Volkswagen Atlas trailer hitch bolts may loosen and separate

    Volkswagen is recalling certain 2022 Atlas and Atlas Cross Sport vehicles because trailer hitch bolts may be insufficiently tightened. Loose bolts could fall out and cause the trailer hitch to separate, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2022·2022-08-31

    Centurion Catheter Kits Recalled Due to Temperature Exposure

    Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.

    Product
    CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1562-2022·2022-08-31

    Enjoy Life and Trader Joe's Soft Baked Cookies Recalled for Hard Plastic Pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies (Snickerdoodle) and Trader Joe's Soft-Baked Snickerdoodles due to potential hard plastic pieces in the products. Consumers should not eat affected packages.

    Product
    Enjoy Life Soft Baked Cookies Snickerdoodle, 6 oz .(170g) UPC 853522000184 Trader Joe's Soft-Baked Snickerdoodles, 6 oz. UPC 0094 0757
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1400-2022·2022-08-31

    ZzzQuil Night Pain Berry Recalled Due to Improper Storage

    ZzzQuil Night Pain Berry 12 FL OZ distributed to Family Dollar Stores from April 30 through June 10, 2022, was held outside appropriate storage temperature conditions, which may compromise medication stability and integrity.

    Product
    ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1365-2022·2022-08-31

    Sunscreen Products Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling multiple sunscreen products that were stored outside appropriate temperature conditions. The storage deviation may have reduced the products' sun protection effectiveness.

    Product
    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2022·2022-08-31

    Drug screening tablets affected by temperature exposure during storage

    McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.

    Product
    Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
    Category
    Medical Device
    Distribution
    Distributed nationwide