The Recall Desk

State

Puerto Rico product recalls

72,919 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 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2251–2275 of 76009

  • SevereFDA (Devices)·Z-1800-2026·2026-04-22

    B. Braun StreamLine Fresenius bloodlines may accumulate arterial air bubbles

    B. Braun is recalling StreamLine Fresenius bloodlines supplied for DaVita because small air bubbles can accumulate in the arterial line under negative pressure. 1,174,271 units are affected.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V256000·2026-04-22

    Toyota RAV4 front seat brackets may be welded improperly

    Toyota is recalling certain 2025 RAV4 vehicles because the front seat brackets for the seat rails may be welded improperly, which can prevent the seat from restraining an occupant in a crash.

    Product
    TOYOTA — TOYOTA RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2026·2026-04-22

    Omnipod 5 insulin pods from 49 lots have torn internal cannulas

    Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.

    Product
    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0453-2026·2026-04-22

    HydroPeptide Clear Alliance benzoyl peroxide serum recalled over benzene contamination

    HydroPeptide Clear Alliance Serum, a 2.5% benzoyl peroxide product, is being recalled because of chemical contamination from the presence of benzene. 9,850 bottles are affected.

    Product
    HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2026·2026-04-22

    Cellex photopheresis kit centrifuge bowls may dislodge and break

    Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.

    Product
    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0454-2026·2026-04-22

    SLMD benzoyl peroxide spot treatment recalled over benzene contamination

    SLMD BP Acne Spot Treatment, 10% benzoyl peroxide, is being recalled because of chemical contamination from the presence of benzene. 2,269 bottles are affected.

    Product
    SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2026·2026-04-22

    Gentuity HF-OCT imaging systems may repeat frames during catheter pullback

    Gentuity is issuing a correction for HF-OCT Imaging Systems because frames may repeat during pullback with Vis-Rx catheters, affecting longitudinal length measurements.

    Product
    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0529-2026·2026-04-22

    Huons lidocaine injection recalled nationwide over lack of sterility assurance

    Lidocaine HCl Injection, USP 1% in 5 mL single dose vials manufactured by Huons is being recalled for lack of assurance of sterility. All lots within expiry are affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2026·2026-04-22

    Arjo Tenor patient lift actuators may lose the ability to hold load

    Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.

    Product
    Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2026·2026-04-22

    Spectra sodium chloride ampules recalled over lack of sterility assurance

    0.9% Sodium Chloride Injection, USP in 10 mL single dose ampules supplied for Spectra Medical Devices is being recalled for lack of assurance of sterility. 7,120,750 ampules are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2026·2026-04-22

    Centurion circumcision kits distributed without the required sterilization process

    Medline is recalling one lot of Centurion Circumcision Kits that was distributed without undergoing the required sterilization process and is therefore not sterile. 640 kits are affected.

    Product
    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V259000·2026-04-22

    Trails West RPM Freeride Recalled for Cooktop Flame Fire Risk

    Trails West is recalling 2027 RPM Freeride recreational trailers because the cooktop flame may invert during furnace operation, increasing fire risk.

    Product
    TRAILS WEST — TRAILS WEST RPM FREERIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2026·2026-04-22

    Elegance anterior cervical plates recalled over burrs on finished product

    Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.

    Product
    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" So
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2026·2026-04-22

    Cytal Wound Matrix 5x5 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0452-2026·2026-04-22

    FarmHouse Fresh benzoyl peroxide night lotion recalled over benzene contamination

    FarmHouse Fresh Midnight Clearing Night Lotion, a 2.5% benzoyl peroxide acne treatment, is being recalled because of chemical contamination from the presence of benzene.

    Product
    FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2026·2026-04-22

    Cytal Burn Matrix recalled over out-of-specification endotoxin test results

    Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.

    Product
    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2026·2026-04-22

    Philips Spectral CT on Rails recalled over three software issues

    Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.

    Product
    Philips Spectral CT on Rails. Model Number: 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2026·2026-04-22

    Yeastone Broth recalled because it may report incorrect susceptibility results

    Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2026·2026-04-22

    iLet Ace insulin pump lock screens can be bypassed by users

    iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.

    Product
    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
    Category
    Medical Device
    Distribution
    Distributed nationwide