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.

16126–16150 of 53092

  • HighFDA (Devices)·Z-1601-2022·2022-08-31

    McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.

    Product
    a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1387-2022·2022-08-31

    Topical ointment recall due to improper storage temperature conditions

    Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.

    Product
    AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1430-2022·2022-08-31

    Multiple eye drop products recalled due to improper storage conditions

    Family Dollar Stores is recalling multiple eye drop products that were held outside appropriate storage temperature conditions. These products were distributed nationwide between April 30 and June 10, 2022.

    Product
    MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ SKU 901961 LUMIFY REDNESS REL EYE DROPS 2.5 FL OZ SKU 998300 FC EYE DROPS ADVANCED 0.5 OZ SKU 902280 distributed to specific Family Dollar Stores…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1391-2022·2022-08-31

    FDA Recalls BC and Goody's Powders Due to Improper Storage Conditions

    Family Dollar Stores is recalling BC Powder and Goody's Powder products due to improper storage temperature conditions. The affected products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1367-2022·2022-08-31

    Multiple Toothpaste and Dental Care Products Recalled for Improper Storage

    Family Dollar Stores is recalling multiple toothpaste and dental care products that were stored outside appropriate temperature conditions, distributed April 30–June 10, 2022.

    Product
    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1418-2022·2022-08-31

    Good Sense Esomeprazole Acid Reducer Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Good Sense Esomeprazole Acid Reducer 20mg bottles due to storage temperature deviations. Affected bottles were distributed between April 30 and June 10, 2022.

    Product
    GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1426-2022·2022-08-31

    GC Milk of Magnesia Recalled for Storage Temperature Deviation

    GC Milk of Magnesia products (Cherry and Mint, 12 fl oz) distributed to Family Dollar Stores have been recalled due to improper storage temperature. The products may not meet quality and performance standards.

    Product
    GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 FL OZ SKU 915623 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1374-2022·2022-08-31

    Antifungal Cream Recalled for Improper Storage Temperature Conditions

    Family Dollar's FS Clotrimazole Anti Fungal Cream is being recalled due to improper storage temperature conditions. The product was distributed nationwide between April 30 and June 10, 2022.

    Product
    FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2022·2022-08-31

    Central Venous Catheter Kits Recalled for Potential Temperature Damage

    McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.

    Product
    TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2022·2022-08-31

    DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

    DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

    Product
    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2022·2022-08-31

    Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators

    The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.

    Product
    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2022·2022-08-31

    Surgical ophthalmic wicks recalled for potential effectiveness loss

    McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1572-2022·2022-08-31

    Enjoy Life Brownie Bites Recalled for Potential Hard Plastic Pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Brownie Bites Rich Chocolate (UPC 819597013290) due to potential hard plastic pieces in the product. No illnesses have been reported.

    Product
    Enjoy Life Brownie Bites Rich Chocolate, 4.76 oz UPC 819597013290
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2022·2022-08-31

    B. Braun Gravity Mixing Container Recalled for Temperature Exposure

    B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.

    Product
    B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2022·2022-08-31

    Enjoy Life Breakfast Ovals Recalled for Potential Hard Plastic Pieces

    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals (Berry Medley) are being recalled due to potential hard plastic contamination. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals Berry Medley, 8.8 oz (250g) UPC 819597012583 and 819597012712
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2022·2022-08-31

    Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss

    Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.

    Product
    BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1401-2022·2022-08-31

    Jet Alert Tablets Recalled for Improper Storage Temperature Conditions

    Jet Alert stimulant tablets distributed nationwide from April to June 2022 are being recalled due to improper storage temperature conditions that may affect product safety and efficacy.

    Product
    JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1372-2022·2022-08-31

    Tylenol and Acetaminophen Products Recalled Due to Improper Storage

    Family Dollar Stores is recalling multiple Tylenol and acetaminophen products due to CGMP deviations involving improper storage temperature conditions. Products were distributed nationwide through specific Family Dollar locations from April 30, 2022 through June 10, 2022.

    Product
    Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for hard plastic pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies Monster (6 oz) due to potential hard plastic pieces. The recall affects 89,736 cases distributed nationwide in the US and Canada with best-by dates between 2/6/2023 and 3/3/2023.

    Product
    Enjoy Life Soft Baked Cookies Monster, 6 oz. UPC 819597013818
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1381-2022·2022-08-31

    Family Dollar Oral Pain Relief Products Recalled for Improper Storage

    Family Dollar recalled multiple oral pain relief products due to storage temperature deviations. The products were distributed to select Family Dollar stores from April 30, 2022 through June 10, 2022.

    Product
    ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2022·2022-08-31

    Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage

    Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.

    Product
    Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1580-2022·2022-08-31

    Bob's Red Mill Amaranth Grain recalled for potential Salmonella contamination

    Bob's Red Mill Organic Amaranth Grain is being recalled due to potential Salmonella contamination. Affected products were distributed across multiple U.S. states and the Philippines.

    Product
    Organic Amaranth Grain Gluten Free, Bob's Red Mill brand, packaged in Standup Pouch (24oz). Each case consists of 4/24 oz. pouches. RETAIL Pouch UPC 0 39978 02910 2. RETAIL Case UPC 10039978029109. Organic Amaranth Grain Gluten Free, Organic Amaranth Grain, packaged in…
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-1431-2022·2022-08-31

    Topical Skincare Products Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling three topical skincare products distributed nationwide due to storage condition violations in manufacturing.

    Product
    ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5 OZ SKU 2097153 CC BLACKHEAD SCRUB 5 OZ SKU 2032021 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2022·2022-08-31

    Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage

    Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
    Category
    Medical Device
    Distribution
    Distributed nationwide