The Recall Desk

State

Puerto Rico product recalls

72,936 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.

What the numbers show

Total
3,090
Critical
366
Severe
625
Most recent
2026-09-02

Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3226–3250 of 76026

  • CriticalFDA (Devices)·Z-1163-2026·2026-02-11

    HOT AXIOS 20mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1162-2026·2026-02-11

    HOT AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0501-2026·2026-02-11

    Swiss chocolate cake mix recalled over an undeclared milk allergen

    B.C. Williams Bakery Service is recalling 95 bags of Swiss Chocolate Cake Mix, sold in 50 lb bags, over an undeclared milk allergen.

    Product
    Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1159-2026·2026-02-11

    AXIOS 6mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1161-2026·2026-02-11

    HOT AXIOS stents recalled over deployment and expansion problems

    Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1160-2026·2026-02-11

    AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V081000·2026-02-11

    Nissan Rogue electronic throttle body gears may break during driving

    Nissan is recalling certain 2024-2025 Rogue vehicles with the 1.5L VC-Turbo engine because the gears in the electronic throttle body assembly may break, causing a loss of drive power.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V080000·2026-02-11

    Nissan Rogue turbo engine bearings may seize causing engine failure

    Nissan is recalling certain 2023-2025 Rogue vehicles with the 1.5L VC-Turbo engine because increased temperatures can break down the engine oil, causing the bearings to seize and the engine to fail.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2026·2026-02-11

    Acetabular liners recalled over packages containing the wrong component

    Encore Medical is recalling 49 EMPOWR acetabular system liners after a package labeled 942-01-40G was found to contain a 942-01-36H liner.

    Product
    EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1244-2026·2026-02-11

    Single use vitrectomy lenses recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0470-2026·2026-02-11

    Apple cinnamon sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Apple and Cinnamon flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2026·2026-02-11

    Home male fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Male Fertility Sperm Test for Home Use (Cassette)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2026·2026-02-11

    pTau 217 plasma cartridges recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2026·2026-02-11

    Amyloid plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2026·2026-02-11

    Plasma ratio test recalled over falsely elevated amyloid classification results

    Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2026·2026-02-11

    pTau 217 plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2026·2026-02-11

    Exploro fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo sodium and hydration tests recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2026·2026-02-11

    Knee tibial inserts recalled over a possible packaging discrepancy

    Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.

    Product
    EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1235-2026·2026-02-11

    Sample preparation systems recalled over a software dispensing error

    Beckman Coulter is recalling 50 CellMek SPS Sample Preparation Systems because a software error dispenses samples close to or touching tube bottoms, removing 60-100 microliters from the final sample.

    Product
    CellMek SPS Sample Preparation System, REF: C44603, with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2026·2026-02-11

    Typhoid antigen tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.

    Product
    S. Typhi/Para Typhi A Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide