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.

26176–26200 of 50460

  • HighFDA (Food)·F-1190-2019·2019-04-03

    Vanns Spices Recalls Casa de Sante Asafetida Powder for Undeclared Gluten

    Vanns Spices is recalling Casa de Sante Asafetida Powder Organic due to undeclared gluten. The recall affects 250 cases sold domestically to one retail account.

    Product
    Casa de Sante, Asafetida Powder Organic, 2.6 oz. (74g) 6 per package
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1196-2019·2019-04-03

    Bauer's Candies Caramels Recalled for Hepatitis A Exposure Risk

    Bauer's Candies, Inc. is recalling Bourbon Sea Salt Caramels due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    Bourbon Sea Salt Bauer's Candies Caramels NET WT 4 oz & 8 oz (bag) & bulk
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-1066-2019·2019-04-03

    Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath

    Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.

    Product
    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2019·2019-04-03

    Surtidoras Bakery Recalls Kid's Rainbow Cookies for Allergen Labeling Error

    Surtidoras Bakery is recalling 50 packages of Kid's Rainbow Cookies because the packaging failed to declare coconut as an allergen in the 'Contains' statement.

    Product
    Kid's Rainbow Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***SOY LECITHIN ***MILK FAT***MODIFIED COCONUT…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1068-2019·2019-04-03

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns

    Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.

    Product
    Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2019·2019-04-03

    LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Risk

    LW Scientific is recalling ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard.

    Product
    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1051-2019·2019-04-03

    BD Synapsys Laboratory Software Recalled for Incorrect Test Order Association

    Becton Dickinson is recalling BD Synapsys version 2.1 because it allowed test orders to be associated with incorrect culture records.

    Product
    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2019·2019-04-03

    Medtronic Pulmonary Vein Ablation Catheter Recalled for Phrenic Nerve Injury Risk

    Medtronic is recalling PVAC GOLD catheters to reduce the potential for phrenic nerve injury during cardiac ablation procedures.

    Product
    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1210-2019·2019-04-03

    Pillsbury Flour Recalled Due to Potential Salmonella Contamination

    Hometown Food Company is recalling Pillsbury Unbleached All Purpose Flour due to potential Salmonella contamination. The product was distributed nationwide.

    Product
    Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper bag retail. 8 bags per shrink wrapped bale wholesale. UPC "0 5150022241 6" - retail unit UPC "0 5150022241 3" - wholesale bale
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2019·2019-04-03

    Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results

    Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.

    Product
    Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2019·2019-04-03

    GE Healthcare Recalls Integrated ECG Cables Due to Short Circuit Risk

    GE Healthcare is recalling 288 integrated ECG cables that can short circuit during defibrillation, potentially diverting 25% of the energy away from the patient.

    Product
    Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2019·2019-04-03

    Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect

    Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.

    Product
    Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1279-2019·2019-04-03

    Surtidoras Bakery Pecan Cookies Recalled for Peanut Oil Allergen Mislabeling

    Surtidoras Bakery is recalling 30 packages of Pecan Cookies because the ingredients list declares peanut oil, but the 'Contains' statement omits it.

    Product
    Pecan Cookies, brand Surtidoras Bakery, net wt. 1.08 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** MILK *** EGGS*** PECANS*** PEANUT OIL ***". The allergens declared in the…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1186-2019·2019-04-03

    Klaire Labs Reduced L-Glutathione Recalled for Containing Lithium Orotate

    ProThera, Inc. is recalling Klaire Labs Reduced L-Glutathione capsules because they are mis-packaged and contain Lithium Orotate instead of the labeled ingredient.

    Product
    Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9
    Category
    Drug
    Distribution
    14 states
  • HighFDA (Food)·F-1277-2019·2019-04-03

    Surtidoras Bakery Recalls Kid's Chocolate Cookies for Undeclared Coconut Allergen

    Surtidoras Bakery is recalling 20 packages of Kid's Chocolate Cookies because the packaging fails to declare coconut in the 'Contains' statement, despite listing it in the ingredients.

    Product
    Kid's Chocolate Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***KIDS CHOCOLATE COOKIES***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***MILK***SOY LECITHIN…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1281-2019·2019-04-03

    Surtidoras Bakery Recalls Vanilla Muffins Due to Undeclared Milk Allergen

    Surtidoras Bakery Inc is recalling 40 packages of Vanilla Muffins distributed in Washington because the packaging failed to declare milk in the 'Contains' statement.

    Product
    Vanilla Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK…
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V271000·2019-04-03

    Ford E-150 and Transit Vans Recalled for Wheelchair Lift Defect

    Mobility Specialists is recalling 2014-2017 Ford E-150 and Transit vans with wheelchair lifts that may fail, posing a tipping risk to users.

    Product
    FORD — FORD, MOBILITY SPECIALISTS E-150, TRANSIT, FORD E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2019·2019-04-03

    LW Scientific ZIP IQ PCV Centrifuge Recalled for Rotor Breakage Risk

    LW Scientific is recalling 142 ZIP IQ PCV Centrifuges because the plastic rotor may break and be ejected, posing a safety hazard to technicians.

    Product
    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1280-2019·2019-04-03

    Surtidoras Bakery Recalls Vanilla Pound Cake for Undeclared Milk Allergen

    Surtidoras Bakery Inc is recalling 60 packages of Vanilla Pound Cake because the packaging failed to declare milk in the 'Contains' statement, despite listing it in the ingredients.

    Product
    Vanilla Pound Cake, brand Surtidoras Bakery, net wt. 15 oz., packaged in flexible plastic film wrap. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOYBEAN OIL***SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK…
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19098·2019-04-03

    Matco Tools Wireless Chargers Recalled Due to Burn Hazard

    Professional Tool Products is recalling Matco Tools wireless chargers because they can overheat and cause burns. Consumers should stop using them and return them for a refund.

    Product
    Matco Tools wireless chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2019·2019-04-03

    LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Hazard

    LW Scientific is recalling 16 ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard to technicians.

    Product
    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2019·2019-04-03

    Philips MultiDiagnost Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2019·2019-04-03

    Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use

    Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.

    Product
    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide