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.

14351–14375 of 53090

  • HighFDA (Devices)·Z-1082-2023·2023-02-15

    Sterile Procedural Trays recalled due to potential sterile packaging puncture

    Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: IM NAIL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2023·2023-02-15

    Medline Procedural Trays Recalled for Blade Packaging Risk

    Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0344-2023·2023-02-15

    Chocolate Almonds Recalled for Undeclared Peanut Allergen

    Skinny Dipped Dark Chocolate Cocoa Almonds are recalled due to undeclared peanut. Consumers with peanut allergies should not consume this product.

    Product
    Skinny Dipped Dark Chocolate Cocoa Almonds, 3.5 oz, packaged in flexible plastic pouches inside cardboard cases. Ingredients: Almonds, Dark Chocolate (Unsweetened Chocolate Processed with Alkali, Cane Sugar, Cocoa Butter, Milk Fat, Sunflower Lecithin, Vanilla), Maple Sugar, Sea…
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1085-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: LS MS PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk

    Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.

    Product
    ANCILLARY PACK-LF. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk

    Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V087000·2023-02-15

    2021-2024 Peterbilt and Kenworth trucks recalled for brake pedal disconnection

    PACCAR is recalling 8,008 Kenworth and Peterbilt trucks (2021-2024) because the brake pedal plunger may disconnect during rapid brake release, causing complete service brake failure and crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 536, 537, T380, 548
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2023·2023-02-15

    Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk

    Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V086000·2023-02-15

    Audi Recalls 2009-2015 Q7 Models Due to Incorrect Weight Rating Label

    Audi is recalling 2009-2015 Q7 vehicles because an incorrect Gross Axle Weight Rating on the certification label may allow the vehicle to be overloaded, increasing crash risk.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2023·2023-02-15

    Vascular Covered Stent Recalled Due to Deployment Failure Risk

    Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.

    Product
    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2023·2023-02-15

    Surgical instrument tracker recalled for structural failure during use

    Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.

    Product
    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0264-2023·2023-02-15

    Ohm Sanitizer Spray Recalled Due to Chemical Contamination

    Urban Electric Power is recalling Ohm Sanitizer Spray nationwide because FDA analysis found the product contains acetaldehyde and acetal above specification limits.

    Product
    Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2023·2023-02-15

    Sterile Trach Pack procedure kits recalled due to blade puncture risk

    Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.

    Product
    TRACH PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0347-2023·2023-02-15

    Kirkland Signature 18 Sandwich Rolls Recalled for Potential Plastic Fragments

    Kirkland Signature 18 Sandwich Rolls may contain Lexan plastic fragments. The affected product was distributed in Montana and Washington.

    Product
    Kirkland Signature 18 Sandwich Rolls Ideal for Hot Dogs, net wt. 54 oz. UPC 0 96619 49013 4. Product is ambient does not require special storage.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·23V085000·2023-02-15

    Tesla Model S Full Self-Driving Beta Software Recall for Unsafe Driving

    Tesla's Full Self-Driving Beta software in 2020 Model S and other models may cause vehicles to drive unsafely through intersections or ignore speed limits. Tesla will provide a free over-the-air software fix.

    Product
    TESLA — TESLA MODEL X, MODEL S, MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk

    Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0342-2023·2023-02-15

    Carrot Cake Recalled for Undeclared Cashew and Almond Allergen

    Super Size Golden Harvest Carrot Cake is being recalled because pieces of cashew and almond were found in the box of walnuts used to make the product. Consumers with tree nut allergies should not consume this product.

    Product
    Super Size Golden Harvest Carrot Cate, Item 06233. Net 9.8 kg 345 oz (21 lb 9 oz). UPC 7 70118-06233 6. Keep Frozen. Manufactured by: The Original Cakerie LTD, 1345 Cliveden Ave, Delta BC Canada V3M 6C7
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1100-2023·2023-02-15

    Precision Delivery Sets recalled due to potential tubing detachment

    Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.

    Product
    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V084000·2023-02-15

    Audi Recalls 2022-2023 S8 and A8 Models for Air Bag Defect

    Audi is recalling 2022-2023 S8 and A8 vehicles because the front-passenger air bag may deploy with excessive force, increasing injury risk.

    Product
    AUDI — AUDI S8, A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

    Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2023·2023-02-15

    Medline Sterile Procedural Trays recalled due to packaging defect risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0348-2023·2023-02-15

    Sour Patch Kids Watermelon Jelly Beans Recalled for Undeclared Yellow No. 5

    Mondelez is recalling Sour Patch Kids Watermelon Jelly Beans due to undeclared FD&C Yellow No. 5, an allergen that could harm consumers with sensitivities to this dye.

    Product
    Sour Patch Kids Watermelon Jelly Beans Net Wt.3 OZ (368g) UPC: 0 70462 00719 0 24 bags per case
    Category
    Food
    Distribution
    Distributed nationwide