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.

4776–4800 of 52939

  • HighFDA (Devices)·Z-1515-2025·2025-04-09

    Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect

    Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.

    Product
    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0681-2025·2025-04-09

    Lean Cuisine Lemon Garlic Shrimp Stir Fry Recalled Due to Foreign Material

    Nestle-USA recalls Lean Cuisine Lemon Garlic Shrimp Stir Fry (10 oz) due to potential wood-like foreign material. Approximately 7,212 cases distributed across 37 states; check Batch Number 4214595511 (Best By September 2025).

    Product
    Lean Cuisine Lemon Garlic Shrimp Stir Fry, NET WT 10 OZ (283g), in a plastic tray with film seal, packaged inside a paperboard carton; 10 consumer units per case
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0719-2025·2025-04-09

    Chocolate Spread Recalled: CACAO BARRY Gianduja Noir Contains Undeclared Milk

    CACAO BARRY Gianduja Noir chocolate product is recalled due to undeclared milk, affecting 180 cases distributed across eight states. Consumers with milk allergies should not consume this product.

    Product
    CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1473-2025·2025-04-09

    Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals

    Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.

    Product
    Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0689-2025·2025-04-09

    Oatmeal Raisin Cookie Dough Recalled for Potential Plastic Contamination

    Craftmark Bakery, LLC is recalling approximately 90 cases of 5000108 Oatmeal Raisin Cookie Dough due to potential plastic foreign material contamination. The affected product was distributed to California, Illinois, Maryland, and Canada.

    Product
    5000108 OATMEAL RAISIN COOKIE DOUGH, 6 poly bags of 30 frozen pucks in a corrugate case, Net Weight: 8.67 kg (19.12 lb)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1511-2025·2025-04-09

    Cordis Vascular Stent System Recalled Due to Incorrect Product Size

    Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.

    Product
    Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1492-2025·2025-04-09

    Terumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data

    Terumo's CDI OneView Hematocrit/Oxygen Saturation Probe may intermittently fail to display oxygen saturation values during clinical use. When this occurs, the monitor displays dashes and triggers a yellow low-limit alarm.

    Product
    Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1517-2025·2025-04-09

    Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1484-2025·2025-04-09

    GE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access

    GE Healthcare recalled Centricity PACS-IW and related medical imaging software due to a security vulnerability allowing service credentials to be identified, potentially enabling unauthorized system access and patient data manipulation.

    Product
    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1500-2025·2025-04-09

    Phoroptor VRx Digital Refraction System head may become loose or detach

    Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.

    Product
    Phoroptor VRx Digital Refraction System Model Numbers: 16241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2025·2025-04-09

    Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0683-2025·2025-04-09

    Lean Cuisine Ravioli Recalled Due to Potential Wood-Like Foreign Material

    Nestle USA is recalling Lean Cuisine Spinach Artichoke Ravioli due to potential wood-like foreign material in the product. The affected 9-ounce frozen meals were distributed across 33 states.

    Product
    Lean Cuisine Spinach Artichoke Ravioli, NET WT 9 OZ (255g), in a plastic tray with film seal, packaged inside a paperboard carton; packed 12 consumer units per case
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0687-2025·2025-04-09

    Julie's Gorditas De Nata Recalled for Undeclared Wheat Allergen

    Julie's Gorditas De Nata is being recalled because the product label fails to declare wheat as an ingredient, posing a risk to consumers with wheat allergies. The recall affects 240 units distributed to two wholesalers.

    Product
    Julie's Gorditas De Nata; Ingredients: Flour, Vegetable Oil, Sugar, Baking Soda, Milk, Sour Cream, Butter, Cream Of Milk, Cinnamon, Vanilla; Net Wt. 16.75 OZ UPC# 0 00202 12018 6
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1477-2025·2025-04-09

    Hemopore nasal wound dressing packaging seal defect may compromise sterility

    Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.

    Product
    Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall

    Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.

    Product
    Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1482-2025·2025-04-09

    Stryker nasal wound dressing recalled for defective sterile packaging seal

    Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.

    Product
    Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E023000·2025-04-08

    Harley-Davidson Recalls Touring Motorcycles for Obstructed Reflectors

    Harley-Davidson is recalling specific 2023-2025 Touring motorcycles because installed accessories may obstruct reflectors, reducing visibility to other road users.

    Product
    EXTERIOR LIGHTING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V213000·2025-04-07

    2022–2023 Nova Bus LFS Transit Buses Engine Wiring Harness Recall

    Nova Bus is recalling certain 2022–2023 LFS transit buses because the engine wiring harness may be incorrect length, risking harness damage and loss of drive power that could cause a crash.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V184000·2025-04-03

    Nova Bus LFS Transit Buses Recalled for Battery Fire Risk

    Nova Bus is recalling 2022-2023 LFS transit buses because high voltage battery hardware may come loose and cause a short circuit, creating a fire risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25210·2025-04-03

    Mini travel hair dryers recalled for electrocution and shock hazard

    XZT mini hair dryers sold on AliExpress lack immersion protection and can cause electrocution or shock if they fall into water while plugged in. No injuries have been reported.

    Product
    Mini Travel Hair Dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide