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.

41551–41575 of 50511

  • HighFDA (Devices)·Z-1231-2014·2014-03-26

    Teleflex Recalls Rusch Endobronchial Tubes Due to Cuff Seal Failure

    Teleflex Medical is recalling Rusch Brochopart endobronchial tubes because the cuff may inflate to one side, preventing a proper seal of the right lung.

    Product
    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1674-2014·2014-03-26

    High Mowing Organic Sprouting Seeds Recalled for Undeclared Wheat

    High Mowing Organic Seed is recalling 655 units of Organic Sprouting Seeds Ancient Eastern Blend because the product contains undeclared wheat.

    Product
    High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1239-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 31,250 latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1672-2014·2014-03-26

    Dayton Nut Specialties Recalls Bar Star Snack Mix for Allergen Mislabeling

    Dayton Nut Specialties Inc is recalling 59 cases of Bar Star Snack Mix because the packaging failed to declare direct allergens including peanuts, tree nuts, soy, and wheat.

    Product
    Bar Star Snack Mix; 25 lb. cardboard carton
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1213-2014·2014-03-26

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System Recalled

    Mar Cor Purification is recalling 232 Millenium HX Portable Reverse Osmosis Systems due to high inlet water pressure and solenoid valve issues that could delay dialysis treatment.

    Product
    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2014·2014-03-26

    Siemens syngo Dynamics PACS Recalled for Potential Patient Data Mixup

    Siemens is recalling 50 syngo Dynamics PACS units because improper error handling could display images for one patient and reports for another, risking misdiagnosis.

    Product
    syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1680-2014·2014-03-26

    Tortillas Mexico Recalls Wheat Tortillas Due to Metal Staple Contamination

    Tortillas Mexico is recalling wheat tortillas because a consumer found a metal staple in a baked tortilla. The firm's metal detector was not functioning.

    Product
    WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1214-2014·2014-03-26

    Alere Triage TOX Drug Screen Recalled for False Negative PCP Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.

    Product
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2014·2014-03-26

    Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

    Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1264-2014·2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2014·2014-03-26

    Medical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology software releases 5.6 through 6.14 because of a potential for erroneous result reporting.

    Product
    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14141·2014-03-26

    SATCO Recalls KolourOne LED Light Bulbs Due to Injury Risk

    SATCO Products is recalling KolourOne LED light bulbs because the metal housing can separate and fall, posing a risk of injury to bystanders.

    Product
    KolourOne Brand Panel Array 2.0 and DUO 2.0 PAR LED Light Bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1236-2014·2014-03-26

    Medline Sterile Foley Catheter Recalled for Blocked Lumen

    Convatec Inc. is recalling Medline Sterile Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1218-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1681-2014·2014-03-26

    CSM Bakery Recalls Chocolate Supreme Cake Layers Due to Foreign Material

    CSM Bakery Products North America is recalling specific lots of 10-inch Chocolate Supreme Cake Layers because they may contain pieces of a red plastic scoop.

    Product
    10" Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1678-2014·2014-03-26

    Tortillas Mexico Recalls Flour Tortillas Due to Metal Detector Malfunction

    Tortillas Mexico is recalling flour tortillas with expiration dates from December 20, 2013, to February 27, 2014, due to a metal detector malfunction that may have allowed metal fragments into the product.

    Product
    FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRANDE 12" 36 OZ UPC Code 1569602224, JUAREZ 8" 24 OZ UPC Code 1569603337, 8" RESTAURANT 23 OZ UPC Code 1569602230, 10" RESTAURANT 28 OZ UPC Code…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1224-2014·2014-03-26

    Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass…
    Category
    Medical Device
    Distribution
    15 states
  • HighUSDA FSIS·pha-032614·2014-03-26

    USDA Issues Public Health Alert for Nutriom Egg Products Unfit for Consumption

    USDA FSIS issued a public health alert for Nutriom LLC egg products because the company refused to expand a recall of items found to be unfit for human consumption due to falsified lab results.

    Product
    FSIS Issues Public Health Alert For Egg Products Unfit For Human Consumption
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2014·2014-03-26

    Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation

    Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.

    Product
    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support…
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2014·2014-03-26

    Elekta Linear Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.

    Product
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2014·2014-03-26

    Convatec SLC Foley Catheters Recalled for Blocked Lumens

    Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.

    Product
    SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Medical Device
    Distribution
    1 state