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.

6476–6500 of 52962

  • HighFDA (Devices)·Z-0368-2025·2024-11-20

    Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally

    Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0132-2025·2024-11-20

    Frozen Potato Wedges Recalled for Undeclared Wheat Allergen

    JR Simplot's frozen seasoned potato wedges are being recalled because the product contains wheat but the label does not declare this allergen. The affected product was distributed to retailers in Pennsylvania only.

    Product
    Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES, VEGE
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0462-2025·2024-11-20

    MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage

    The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2025·2024-11-20

    Surgical instrument kits recalled for potential loose metal flake hazard

    Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.

    Product
    Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2025·2024-11-20

    IV Fluid Container Bags Recalled for Potential Leaks During Filling

    The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.

    Product
    SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2025·2024-11-20

    Halyard C Section Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

    Product
    Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2025·2024-11-20

    Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2025·2024-11-20

    Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat

    Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.

    Product
    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2025·2024-11-20

    Medical Surgical Kit Recalled for Potential Loose Metal Flake Hazard

    AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.

    Product
    Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2025·2024-11-20

    Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes

    AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.

    Product
    Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0042-2025·2024-11-20

    Trinity Gold Nutrition Capsules Recalled for Undeclared Drug Ingredients

    Trinity Gold Nutrition capsules (Lot IN-030, expiring November 2027) have been recalled for containing three undeclared pharmaceutical ingredients: acetaminophen, diclofenac, and phenylbutazone. These unapproved drugs could cause health risks through medication interactions and adverse effects.

    Product
    Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2025·2024-11-20

    Halyard TOTAL KNEE Medical Convenience Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2025·2024-11-20

    Halyard Pacemaker Drape Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.

    Product
    Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2025·2024-11-20

    Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments

    AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2025·2024-11-20

    Halyard GYN TRAY surgical kits recalled for loose metal flakes

    AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2025·2024-11-20

    Halyard surgical kit recalled for loose metal flakes in forceps and clamps

    AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2025·2024-11-20

    Surgical instrument kits recalled for loose metal flakes

    AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.

    Product
    Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2025·2024-11-20

    Halyard ENDOVASCULAR surgical kits recalled for loose metal flakes

    Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.

    Product
    Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2025·2024-11-20

    Lanthanum Carbonate Chewable Tablets Recalled for Crushed and Broken Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets (1000mg) distributed nationwide due to complaints of crushed and broken tablets that fail manufacturing specifications.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2025·2024-11-20

    IV Fluid Containers Recalled for Leakage Risk During Filling

    The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.

    Product
    CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2025·2024-11-20

    IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall

    The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.

    Product
    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2025·2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.

    Product
    Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2025·2024-11-20

    MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur

    The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
    Category
    Medical Device
    Distribution
    Distributed nationwide