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.

16801–16825 of 53124

  • HighFDA (Devices)·Z-1330-2022·2022-07-13

    Ossur Variflex Suba Junior prosthetic foot may crack under impact

    Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.

    Product
    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1405-2022·2022-07-13

    Plant-Based Yogurt Recalled Due to Potential Glass Contamination

    EAT REAL FOOD LLC is recalling Culina Plant Based Blueberry Lavender Yogurt due to potential glass fragments. Affected lots were distributed nationwide with best-by dates in October and November 2022.

    Product
    Plant Based Yogurt Culina Blueberry Lavender Nt Wt 5 oz. (142 g) UPC 854724007117 packaged in glass container 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1410-2022·2022-07-13

    Plant-based yogurt recalled due to potential glass contamination

    EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Mango Orange Blossom due to potential glass contamination. The affected lot code is 07422CBCUCYMOB0723 with best-by date 11/13/2022, distributed nationwide.

    Product
    Plant Based Yogurt Culina Mango Orange Blossom Nt Wt 5 oz. (142 g) UPC 854724007230 packaged in glass container 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1424-2022·2022-07-13

    Paris Brothers Mild Cheddar Cheese Recalled for Listeria Risk

    Paris Brothers Inc is recalling Mild Cheddar Cheese (UPC 033954252225) due to Listeria in environmental samples. The affected lots (05042022 and 05052022) were distributed to wholesalers, retailers, and food service establishments.

    Product
    MILD CHEDDAR CHEESE Ingredients: Pasteurized Milk, Cheese Culture, Salt, Enzymes and Annatto DISTRIBUTED BY PARIS BROTHERS, INC. KANSAS CITY, MO 64161 UPC: 033954252225 Net wt. 1 LB(16OZ) 453G Carton Label (not available to consumers) ITEM ID: 02201804 PARIS…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1406-2022·2022-07-13

    Plant Based Yogurt Recall Due to Potential Glass Contamination

    EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Bourbon Vanilla in 5 oz. glass jars nationwide due to potential glass fragments in the product. Consumers should not consume products with the affected lot codes.

    Product
    Plant Based Yogurt Culina Bourbon Vanilla Nt Wt 5 oz. (142 g) UPC 854724007094 packaged in glass container 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2022·2022-07-13

    Rayner RayOne Intraocular Lens Systems Mislabeled with Incorrect Lens Strength

    Rayner is recalling RayOne intraocular lens injection systems because the outer package is mislabeled and contains a different lens strength than indicated. Approximately 162 devices were distributed in 13 US states.

    Product
    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1422-2022·2022-07-13

    Milton Creamery Prairie Breeze Cheese Recalled for Listeria Risk

    Milton Creamery Prairie Breeze cheese is being recalled due to environmental samples testing positive for Listeria. The product was distributed to wholesale, retail, and food service locations.

    Product
    MILTON CREAMERY PRAIRIE BREEZE Pasteurized Cow's Milk, Cultures, Salt, Veg.Rennet www.miltoncreamery.com 641-656-4094 Carton Label (not available to consumers) ITEM ID: 02074704 PARIS BROTHERS, INC 8800 NE UNDERGROUND DR KANSAS CITY, MO 64161 (816) 455-4189 MILTON…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1408-2022·2022-07-13

    Plant-Based Strawberry Rose Yogurt Recalled for Potential Glass

    Culina Strawberry Rose plant-based yogurt is being recalled because glass may be present in the product. The recall affects 13,725 cases distributed nationwide.

    Product
    Plant Based Yogurt Culina Strawberry Rose Nt Wt 5 oz. (142 g) UPC 854724007100 packaged in glass container 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2022·2022-07-13

    ABL800 Flex Analyzer Recalled for Potential Measurement Bias

    Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.

    Product
    ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1409-2022·2022-07-13

    Plant-Based Yogurt Recalled for Potential Glass Contamination

    EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Peach Cashew due to potential glass contamination. The product was distributed nationwide in 13,725 cases.

    Product
    Plant Based Yogurt Culina Peach Cashew Nt Wt 5 oz. (142 g) UPC854724007254 packaged in glass container 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2022·2022-07-13

    EEA Autosuture Circular Staplers Recalled for Staple Guide Detachment Risk

    Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.

    Product
    EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1184-2022·2022-07-13

    Boric Acid Vaginal Suppositories Recalled Due to Manufacturing Control Defects

    Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.

    Product
    Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2022·2022-07-13

    Abbott TactiCath Ablation Catheter System Error Display Malfunction

    Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.

    Product
    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2022·2022-07-13

    Imaging system software displays mirrored CT images during data loading

    Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.

    Product
    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1421-2022·2022-07-13

    Soft Ripened Brie D'Amir Cheese Recalled Due to Listeria Risk

    Paris Brothers Inc recalls Brie D'Amir soft ripened cheese due to Listeria detected in environmental samples. The affected product was distributed to wholesale warehouses and retail food establishments.

    Product
    SOFT RIPENED CHEESE - DOUBLE CREME BRIE D'AMIR Imported by Epicure Foods Corp. Flanders NJ, 07836 INGREDIENTS: Pasteurized Milk, Salt, Lactic Ferments, Enzymes, Ripening Cultures. PRODUCT OF FRANCE Carton Label (not available to consumers): ITEM ID: 02050003 PARIS…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1335-2022·2022-07-13

    VERIGENE Enteric Pathogens Test may yield false negative results

    Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.

    Product
    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1186-2022·2022-07-13

    Estriol Vaginal Cream Recalled Due to Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.

    Product
    Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1420-2022·2022-07-13

    Raw milk cheese recalled due to Listeria contamination

    Paris Brothers Inc is recalling WIEBE DAIRY Raw Milk Cheese because environmental samples tested positive for Listeria. The product was distributed to wholesale and retail locations.

    Product
    WIEBE DAIRY RAW MILK CHEESE Ingredients: Grade A Raw milk, salt, cheese culture, enzyme, annatto Cottonwood River RESERVE www.jasonwiebedairy.com Durham, KS 67438 Plant # 20-037 Carton Label (not available to consumers) ITEM ID: 02000002 PARIS BROTHERS, INC. 8800 NE…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1401-2022·2022-07-13

    Bix Produce diced spinach recalled for plastic contamination

    Bix Produce Company LLC is recalling diced spinach due to plastic contamination. The recall affects 1,181 cases distributed in Wisconsin with use-by dates between January and June 2022.

    Product
    Bix Produce Diced Spinach, Item # 15939. packaged in 2lb bags, with 5 bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1331-2022·2022-07-13

    Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction

    Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400T Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2022·2022-07-13

    Omnera 400A Digital Radiographic System: Electrical Short Circuit Hazard

    Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400A Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1400-2022·2022-07-13

    SoDelicious DairyFree Frozen Dessert Cones Recalled for Undeclared Peanut

    SoDelicious DairyFree Wondermilk Salted Caramel Sundae cones are recalled due to peanut contamination. Some cartons mistakenly contain peanut pieces, posing a serious risk to consumers with peanut allergies.

    Product
    SoDelicious DairyFree Wondermilk Dairy Free Frozen Dessert Salted Caramel Sundae, 3 - 4 fl oz (12 fl oz) cones per carton. UPC 0 36632 07821 6 Manufactured by/for: So Delicious Dairy Free, Eugene, OR 97402. Keep frozen.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1318-2022·2022-07-13

    Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk

    Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.

    Product
    Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1427-2022·2022-07-13

    Cervasi Pecorino Romano Cheese Recalled Due to Listeria

    Cervasi Pecorino Romano Cheese is being recalled by Paris Brothers Inc due to Listeria contamination detected in environmental samples at the production facility.

    Product
    PRODUCT OF ITALY Cervasi PECORINO ROMANO CHEESE Ingredients: Sheep's Milk, Rennet, Salt. Contains: Sheep's Milk Imported by Paris Brothers, Inc. Kansas City, MO 64161 Cervasi.com Carton Label (not available to consumers) ITEM ID: 06010002 PARIS BROTHERS, INC 8800 NE…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1185-2022·2022-07-13

    Estriol Vaginal Cream Recalled for Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol 1mg/gm Vaginal Cream due to insanitary manufacturing conditions and lack of adequate processing controls identified during FDA inspection. The product was distributed nationwide.

    Product
    Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide