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.

13876–13900 of 22165

  • HighFDA (Devices)·Z-0020-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.

    Product
    Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2666-2023·2023-10-11

    Siemens ADVIA Chemistry Iron_2 Reagents Recalled for Potential Measurement Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Iron_2 Reagents due to a potential positive bias in test results that could affect the accuracy of Quality Control and patient iron level measurements.

    Product
    ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1699-2023·2023-10-11

    Kratom edible product recalled due to unapproved food additive

    The Crooked Row kratom edible product is recalled because kratom is an unapproved food additive. Consumers who purchased this product should not use it.

    Product
    The Crooked Row - Nkratable 4.5g per bite - 3 bites per pack
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0003-2024·2023-10-11

    Ephedrine Injectable Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2023·2023-10-11

    Veran Navigation System Biopsy Needle Devices: Electromagnetic Compatibility Issue

    Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.

    Product
    Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2024·2023-10-11

    Real Intelligence CORI knee surgery software missing planning stage

    Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.

    Product
    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2024·2023-10-11

    FDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue

    Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.

    Product
    HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2024·2023-10-11

    Cardiac guide catheter recalled for incorrect tip curve shape

    Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2024·2023-10-11

    LFS flat screen arm system surgical lamp bracket stopper block defect

    The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.

    Product
    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0010-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2024·2023-10-11

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.

    Product
    fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0002-2024·2023-10-11

    Ketamine syringes recalled for lack of sterility assurance

    CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0017-2024·2023-10-11

    Fentanyl and Bupivacaine Injectable Bags Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V759000·2023-10-11

    Solar Panels May Detach from Thor Rize and Scope Motorhomes

    Thor Motor Coach is recalling 2021-2024 Rize and Scope motorhomes because the solar panel frame may fracture at the mounting bolts and detach, creating a road hazard.

    Product
    THOR MOTOR COACH — 2021 THOR MOTOR COACH RIZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1700-2023·2023-10-11

    Sweet & Spicy BBQ Sauce Recalled for Undeclared Fish Allergen

    The Fresh Chile Company is recalling Sweet & Spicy BBQ sauce due to an undeclared fish (anchovies) allergen on the label. Consumers with fish allergies may be at risk.

    Product
    Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Medium. 19 fluid ounce glass jar 19 fl oz. (510g) , with a metal screw top lid.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0018-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2023·2023-10-11

    Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results

    Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.

    Product
    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0024-2024·2023-10-11

    Fentanyl in Dextrose Syringes Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.

    Product
    fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V708000·2023-10-09

    2023 Cadillac XT6, XT5, and GMC Acadia: illegible tire certification label

    General Motors is recalling 2023 Cadillac XT6, XT5, and GMC Acadia vehicles due to illegible tire size information on the driver's side certification label. The illegibility may result in incorrect tires being installed, increasing crash risk.

    Product
    CADILLAC — 2023 CADILLAC XT6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V709000·2023-10-09

    2020-2021 GMC Acadia rearview camera may fail due to improper connector crimping

    General Motors is recalling certain 2020-2021 GMC Acadia vehicles with defective rearview camera coaxial cables that may fail or malfunction. The improperly crimped connectors can reduce rear visibility and increase crash risk.

    Product
    GMC — 2020 GMC ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V712000·2023-10-09

    2022 Subaru Outback Windshield Defect May Cause Detachment in Crash

    Subaru is recalling 42 2022 Outback and Impreza vehicles due to incorrect paint clearcoat that may insufficiently bond the windshield. The windshield could detach during a crash, increasing injury risk.

    Product
    SUBARU — 2022 SUBARU OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V710000·2023-10-09

    2023 Cadillac LYRIQ Instrument Panel Software Error May Cause Display to Go Blank

    General Motors is recalling certain 2023 Cadillac LYRIQ vehicles due to a software error that may cause the instrument panel display to go blank, potentially preventing drivers from seeing critical safety information.

    Product
    CADILLAC — 2023 CADILLAC LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V567000·2023-10-08

    2022-2023 Chevrolet Bolt EV air bag deployment defect recall

    General Motors is recalling certain 2022-2023 Chevrolet Bolt EV vehicles because the instrument panel cover may lack a required perforation, preventing proper passenger-side air bag deployment.

    Product
    CHEVROLET — 2022 CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V566000·2023-10-08

    2022-2023 Toyota Tundra Fuel Tube Chafing Damage Recall

    Toyota is recalling 2022-2023 Tundra and Tundra Hybrid vehicles because the plastic fuel tube may chafe against brake lines and leak fuel, creating a fire risk.

    Product
    TOYOTA — 2022 TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V565000·2023-10-08

    2023 Jeep Wrangler Brake Light Obstruction Recall

    Chrysler is recalling certain 2023 Jeep Wrangler vehicles because the spare tire may obstruct the center high-mount brake light, reducing visibility to other drivers and increasing crash risk.

    Product
    JEEP — 2023 JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide