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.

9176–9200 of 53036

  • HighFDA (Devices)·Z-1597-2024·2024-04-24

    RENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk

    Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.

    Product
    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2024·2024-04-24

    Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects

    Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.

    Product
    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling Intera 1.5T magnetic resonance systems worldwide because the patient support table floor plate may be incorrectly installed, potentially affecting table stability and patient safety.

    Product
    Intera 1.5T Power/Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2024·2024-04-24

    MRI patient support table floor plate may be incorrectly installed

    Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.

    Product
    Intera 1.0T Power/Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2024·2024-04-24

    MRI system patient support table floor plate installation defect

    Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.

    Product
    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips North America is recalling 7 GYROSCAN T5 MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create a safety risk during patient table use.

    Product
    GYROSCAN T5, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0446-2024·2024-04-24

    Thyroid pharmaceutical ingredient recalled for failed stability specifications

    Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.

    Product
    S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2024·2024-04-24

    Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error

    Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.

    Product
    Identity Imprint PS Tibial Tray Size 4: Lot 540287
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0447-2024·2024-04-24

    Specialty Process Labs Recalls Thyroid USP Drug Ingredient for Failed Stability

    Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.

    Product
    S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2024·2024-04-24

    Smiths Medical syringe pumps recalled for molding defect in barrel clamp guide

    Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.

    Product
    Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1553-2024·2024-04-24

    Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

    Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

    Product
    Achieva 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1152-2024·2024-04-24

    Peanut Butter Filled Iced Donuts Recalled for Metal Contamination

    Weis Markets is recalling Peanut Butter Filled Iced Donuts due to foreign material (metal) found in the product. Affected donuts were distributed at a retail store in Pennsylvania with sell-by dates between March 15–18, 2024.

    Product
    Bakery Item Peanut Butter Filled Iced Donuts 6 ct. scale UPC: 2128800005501 packaged in a cardboard box. Product is also separately in the self service case in the store bakery. Customers can put their selected donut(s) in a bag or clamshell container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1598-2024·2024-04-24

    Siemens Artis X-ray systems cooling malfunction may halt procedures

    Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.

    Product
    Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q bipl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2024·2024-04-24

    Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification

    Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1174-2024·2024-04-24

    Great Value Sandwich Cookies Recalled for Plastic Foreign Material

    Shearer's Foods is recalling Great Value Twist & Shout Strawberry Creme Sandwich Cookies due to possible plastic fragments in the product. Affected items have a best-if-used-by date of September 11, 2024.

    Product
    Great Value Twist & Shout Strawberry Creme Sandwich Cookies, Net WT 15.35 oz. box containing film wrapped trays of stacked cookies. 12 boxes per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1540-2024·2024-04-24

    Smiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes

    Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.

    Product
    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1538-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss

    Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2024·2024-04-24

    Trocar Needle Recall Due to Packaging Seal Strength Defect

    Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.

    Product
    Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G013
    Category
    Medical Device
    Distribution
    Distributed nationwide