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.

3251–3275 of 76026

  • 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-1306-2026·2026-02-11

    Amyloid 1-42-N plasma calibrators recalled over falsely elevated results

    Fujirebio Diagnostics is recalling 128 units of Lumipulse G beta-Amyloid 1-42-N Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2026·2026-02-11

    Ovulation test devices recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    LH One Step Ovulation Test Device (Urine)
    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-1236-2026·2026-02-11

    Susceptibility test cards recalled over false resistant antibiotic results

    bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.

    Product
    VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0479-2026·2026-02-11

    Lemon pie sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Lemon Pie flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2026·2026-02-11

    Subretinal injection cannulas 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
    25GA Subretinal Injection Cannula VS0220.25
    Category
    Medical Device
    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-1299-2026·2026-02-11

    X-ray systems recalled over welded contactor contacts that may overheat

    FUJIFILM Healthcare Americas is recalling 16 FDR Visionary Suite systems because welded contactor contacts may keep supplying current after the device is switched off.

    Product
    FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
    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-1252-2026·2026-02-11

    Injection kits recalled over voids in sterile Tyvek 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
    Vortex Surgical I2 Injection Kit, VS0500
    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-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-1255-2026·2026-02-11

    Backflush instruments recalled over voids in sterile 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
    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0472-2026·2026-02-11

    Passion fruit sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Passion Fruit flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2026·2026-02-11

    pTau 217 plasma calibrators recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2026·2026-02-11

    Vitrectomy convenience kits recalled over voids in sterile 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
    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2026·2026-02-11

    Vivoo pH tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo pH Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2026·2026-02-11

    Urinalysis test strips recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2026·2026-02-11

    Retractable membrane polishers recalled over voids in sterile 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
    Tecfen Retractable Membrane Polisher, QTPR1267-23
    Category
    Medical Device
    Distribution
    Distributed nationwide