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.

13476–13500 of 53086

  • HighFDA (Devices)·Z-1466-2023·2023-05-03

    Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings

    Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.

    Product
    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2023·2023-05-03

    Surgical forceps may fail to open during endoscopic procedures

    Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.

    Product
    FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0752-2023·2023-05-03

    Enriched Hot Dog Buns Recalled for Undeclared Sesame Allergen

    Our Family White Hot Dog Enriched Buns are being recalled due to undeclared sesame. The recall affects approximately 28,700 units distributed in Michigan, Ohio, Indiana, and Illinois, and poses a risk to consumers with sesame allergies.

    Product
    Our Family White Hot Dog Enriched Buns, 8 count 12oz. retail unit UPC 0-70253-75107-3
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1468-2023·2023-05-03

    Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility

    Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.

    Product
    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1436-2023·2023-05-03

    Sterile surgical C-section kit light handle covers recalled for separation risk

    ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2023·2023-05-03

    Biopsy forceps may fail to open when endoscope is bent

    Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.

    Product
    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0554-2023·2023-05-03

    Tadalafil Tablets Recalled Due to Manufacturing Practice Violations

    Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0569-2023·2023-05-03

    Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination

    Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.

    Product
    FYREMADEL — FYREMADEL (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0769-2023·2023-05-03

    Popped water lily seeds recalled due to undeclared milk

    Karma Spices and Trading Company is recalling Karma White Cheddar Cheese Popped Water Lily Seeds because the product contains undeclared milk. The recall affects 1,423 units distributed in Michigan and online.

    Product
    Karma White Cheddar Cheese Popped Water Lily Seeds packed in 1.5oz pouches UPC: 617201892589
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V315000·2023-05-03

    Capacity Recalls 2022 TJ Series Trucks Due to Missing Seat Clip

    Capacity of Texas is recalling 2022 TJ 5000, 6500, and 9000 trucks because a missing safety clip on the passenger jump seat could allow it to fall, increasing injury risk.

    Product
    CAPACITY — CAPACITY TJ 9000, TJ 6500, TJ 5000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2023·2023-05-03

    Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging

    Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.

    Product
    (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1467-2023·2023-05-03

    Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions

    Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.

    Product
    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2023·2023-05-03

    VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr

    Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.

    Product
    VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2023·2023-05-03

    Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

    ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2023·2023-05-03

    GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling

    Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.

    Product
    GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2023·2023-05-03

    Digital X-ray System Arm May Break, Posing Injury Risk

    FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.

    Product
    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0762-2023·2023-05-03

    Rajbhog Sweets Orange Jalebi Recalled Due to Undeclared Milk Allergen

    Rajbhog Sweets Orange Jalebi is recalled because the product label does not clearly disclose milk as an allergen, despite containing butter. Consumers with milk allergies who purchase this product face a health risk.

    Product
    Rajbhog Sweets Orange Jalebi Net Weight: 10 oz. UPC 3542647018 packaged in a plastic container and in bulk sold by weight
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0543-2023·2023-05-03

    Peritoneal dialysis solution recalled due to sterility assurance concerns

    Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2023·2023-05-03

    VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect

    Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.

    Product
    VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2023·2023-05-03

    Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect

    Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.

    Product
    Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2023·2023-05-03

    Sterile Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

    Product
    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0767-2023·2023-05-03

    Baklava from Paximadi Co recalled for undeclared soybean oil

    Paximadi Co LLC is recalling Baklava manufactured on 3/29/2023 for undeclared soybean oil. Consumers with soybean allergies should not consume the product.

    Product
    Baklava, 2 oz. Each cardboard box contains 25 units (net wt. 50 oz). No UPC. The Ingredients statement declares: Fillo (Enriched, Non-Bromine Bleached Wheat Flour, Thiamin, Mononitrate, Riboflavin, Niacin, Iron, Folic Acid, Water, Corn Starch, Vegetable Oil (Corn or…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1437-2023·2023-05-03

    Surgical Convenience Kits Recalled Due to Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2023·2023-05-03

    Surgical forceps may fail to open when endoscope shaft is bent

    Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.

    Product
    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V312000·2023-05-03

    Volkswagen ID.4 Door Handles May Open Unexpectedly Due to Water Intrusion

    Certain 2021-2022 Volkswagen ID.4 vehicles have door handles that may allow water to enter the circuit board assembly, potentially causing doors to open unexpectedly while driving. Volkswagen will update vehicle software and inspect door handles at no cost to owners.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide