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.

3151–3175 of 76026

  • HighFDA (Drugs)·D-0335-2026·2026-02-18

    Thiamine injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 10,548 bags of thiamine HCl 500 mg in sodium chloride injection over a lack of assurance of sterility.

    Product
    thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2026·2026-02-18

    Sterile resuture packs recalled over open swabstick applicator seals

    Medline is recalling 216 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2026·2026-02-18

    Azurion 3 M15 systems recalled over tables that may move unexpectedly

    Philips is recalling 802 units of the Azurion 3 M15 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0308-2026·2026-02-18

    Estradiol 10mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 24,099 pellets of ESTRADIOL, 10 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0328-2026·2026-02-18

    Testosterone 100mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 4,599 pellets of Testosterone 100mg, Triamcinolone Acetonide 20mcg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2026·2026-02-18

    Spectral CT 7500 scanners recalled over rotor fasteners that may loosen

    Philips is recalling 3 units of the Spectral CT 7500 on Rails because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

    Product
    Spectral CT 7500 on Rails; Product Code (REF): 728334;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0331-2026·2026-02-18

    Testosterone and anastrozole pellets recalled over potential metal particulate

    Asteria Health is recalling 1,464 pellets of Testosterone 100mg, Anastrozole 4mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1313-2026·2026-02-18

    Adult intubation trays recalled over a smaller catheter packed inside

    Medline is recalling 130 Adult Intubation Trays because an 8 Fr suction catheter may have been packed in place of the required 14 Fr catheter.

    Product
    Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2026·2026-02-18

    Testosterone 100mg single pellets recalled over potential metal particulate

    Asteria Health is recalling 153,498 pellets of Testosterone, 100 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0333-2026·2026-02-18

    Acyclovir injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 1,057 bags of acyclovir sodium 200 mg in 100 mL sodium chloride injection over a lack of assurance of sterility.

    Product
    acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2026·2026-02-18

    Transport bag kits recalled over a Tyvek bag seal issue

    AVID Medical is recalling 1,500 Halyard Transport Bag Kits because a Tyvek bag seal issue may compromise the sterility of the kit.

    Product
    Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2026·2026-02-18

    Suction catheter kits recalled over a smaller catheter packed inside

    Medline is recalling 141,971 of its 14 Fr Suction Catheter Kits because an 8 Fr catheter may have been packed in place of the required 14 Fr catheter.

    Product
    Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2026·2026-02-18

    Azurion 5 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 326 units of the Azurion 5 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2026·2026-02-18

    Vancomycin 2 gram bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling vancomycin HCl 2 grams in 500 mL sodium chloride injection over a lack of assurance of sterility.

    Product
    vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0313-2026·2026-02-18

    Estradiol 22mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 133 pellets of ESTRADIOL, 22 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2026·2026-02-18

    Testosterone 75mg and anastrozole pellets recalled over metal particulate matter

    Asteria Health is recalling 670 pellets of Testosterone 75mg, Anastrozole 4mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0329-2026·2026-02-18

    Testosterone 200mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 7,840 pellets of Testosterone 200mg, Triamcinolone Acetonide 40mcg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0314-2026·2026-02-18

    Estradiol 25mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 2,442 pellets of ESTRADIOL, 25 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2026·2026-02-18

    Breast biopsy needles recalled over particulates that can enter tissue

    Hologic is recalling 681,870 Brevera Breast Biopsy System disposable 9 gauge needles because particulates in affected devices can be deposited into breast tissue during use.

    Product
    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2026·2026-02-18

    Anesthesia artline packs recalled over open swabstick applicator seals

    Medline is recalling 120 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0320-2026·2026-02-18

    Testosterone 50mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 70,959 pellets of Testosterone, 50.0 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2026·2026-02-18

    Azurion 7 B20 systems recalled over tables that may move unexpectedly

    Philips is recalling 1 of the Azurion 7 B20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2026·2026-02-18

    Dressing change trays recalled over open swabstick applicator seals

    Medline is recalling 8,445 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0312-2026·2026-02-18

    Estradiol 20mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 1,475 pellets of ESTRADIOL, 20 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
    Category
    Drug
    Distribution
    Distributed nationwide