The Recall Desk

State

Puerto Rico product recalls

72,940 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.

Which agencies issued them

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3476–3500 of 76030

  • CriticalFDA (Devices)·Z-1147-2026·2026-01-28

    Full electric lightweight homecare beds recalled over pendants that may overheat

    Medline is recalling 35,694 units of the Full Electric Lightweight Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V050000·2026-01-28

    Ducati motorcycle rear brake hose may fail from excessive heat

    Ducati is recalling certain 2025-2026 Streetfighter V4 and Panigale V4 motorcycles because excessive heat may damage the rear brake hose, resulting in a sudden loss of the rear brakes.

    Product
    DUCATI — DUCATI STREETFIGHTER V4, PANIGALE V4, STREETFIGHTER V4 S, PANIGALE V4 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2026·2026-01-28

    Icosapent ethyl capsules recalled as subpotent after capsule contents leaked

    Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.

    Product
    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2026·2026-01-28

    PET scanners recalled over a streaking artifact in clinical images

    GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.

    Product
    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Waste management vascular trays recalled over inflation handles that may detach

    Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2026·2026-01-28

    Angiographic inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Inflation Device, for angiographic use REF: IS-30-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2026·2026-01-28

    Custom procedure kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2026·2026-01-28

    Endoluminal vision probe bags recalled over compromised sterile pouch seals

    Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2026·2026-01-28

    Angioplasty packs recalled over inflation handles that may detach

    Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2026·2026-01-28

    SIGMA Spectrum infusion pumps recalled over defective grease on the gears

    Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.

    Product
    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0294-2026·2026-01-28

    Bulk thyroid drug substance recalled as subpotent from one lot

    Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.

    Product
    Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2026·2026-01-28

    LDL cholesterol assays recalled over triglyceride interference causing biased results

    Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.

    Product
    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
    Category
    Medical Device
    Distribution
    52 states
  • HighNHTSA·26V049000·2026-01-28

    Toyota Prius models recalled for unexpected rear door opening risk

    Toyota is recalling certain 2023–2026 Prius and Prius Prime models because water may enter the rear door switch, causing an unlocked door to open unexpectedly while driving. This increases injury risk.

    Product
    TOYOTA — TOYOTA PRIUS PLUG-IN HYBRID, PRIUS PRIME, PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2026·2026-01-28

    Custom inflation kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2026·2026-01-28

    basixCOMPAK inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2026·2026-01-28

    Plum Solo pumps recalled over hard limit messages blocking flush programming

    ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2026·2026-01-28

    Mini Cuban loaf cake with raisins recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 260 master cases (3,120 loaf cakes) of Mini Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.

    Product
    ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2026·2026-01-28

    Plum Duo infusion pumps recalled over blocked piggyback flush programming

    ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2026·2026-01-28

    iX series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2026·2026-01-28

    TRAM powered lift devices recalled over potential strap fraying

    Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.

    Product
    Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
    Category
    Medical Device
    Distribution
    Distributed nationwide