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.

Which agencies issued them

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.

2476–2500 of 76009

  • HighFDA (Devices)·Z-1681-2026·2026-04-08

    CPX 4 SILTEX low height expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2026·2026-04-08

    Medline endoscopy kits contain recalled Olympus biopsy valves shedding fragments

    Medline is recalling BAL and ENDO kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

    Product
    Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2026·2026-04-08

    Medline ENFit G-tube connector kits may leak from dimensional defect

    Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.

    Product
    Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2026·2026-04-08

    da Vinci monopolar curved scissors recalled over frayed grip cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2026·2026-04-08

    Philips Azurion 7 M20 X-ray may not start from foot switch

    Philips has identified instances where X-ray imaging on the Azurion 7 M20 may not initiate, or may run intermittently, when the wired foot switch is used. 5,167 units are affected.

    Product
    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2026·2026-04-08

    MiniMed 620G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 620G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 620G Insulin Pump (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2026·2026-04-08

    VOLT locking screw taps swapped between lots carry incorrect thread

    The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2026·2026-04-08

    Paradigm REAL-Time Revel pump delivery varies with pump height changes

    Medtronic is recalling Paradigm REAL-Time Revel insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2026·2026-04-08

    Paradigm REAL-Time Veo pump delivery varies with pump height changes

    Medtronic is recalling Paradigm REAL-Time Veo insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2026·2026-04-08

    MiniMed 770G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 770G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2026·2026-04-08

    Burlington Medical caps may lose radiation attenuation over time

    Burlington Medical is recalling protective caps made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.

    Product
    Burlington Medical, Caps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2026·2026-04-08

    Leader artificial tears 15 mL recalled over sterility assurance failure

    Leader Artificial Tears 15 mL, containing polyvinyl alcohol and povidone, are being recalled for lack of assurance of sterility.

    Product
    LEADER ARTIFICIAL TEARS 15 ML — LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0413-2026·2026-04-08

    GoodSense original formula eye drops recalled over sterility assurance

    GoodSense Eye Drops Original Formula, containing tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.

    Product
    GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2026·2026-04-08

    Oxoid Microbact Listeria kit may identify the incorrect organism

    Oxoid, part of Thermo Fisher Scientific, is recalling one lot of the Microbact 12L Listeria identification kit because it may identify the incorrect organism.

    Product
    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2026·2026-04-08

    Medline bronchoscopy kits contain Olympus biopsy valves that shed fragments

    Medline is recalling six bronchoscopy and thoracic kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

    Product
    Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRON
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2026·2026-04-08

    da Vinci permanent cautery hook recalled over frayed pitch cables

    Intuitive Surgical is recalling da Vinci S and Si Permanent Cautery Hook Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.

    Product
    Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2026·2026-04-08

    Medline thoracic robot kits contain recalled Olympus biopsy valves

    Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.

    Product
    THORACIC ROBOTS, DYNJ908777B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2026·2026-04-08

    Burlington Medical kilts may lose radiation attenuation over time

    Burlington Medical is recalling kilts made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.

    Product
    Burlington Medical, Kilt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2026·2026-04-08

    MiniMed 530G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 530G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 530G Insulin Pump (MMT-551, MMT-751)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2026·2026-04-08

    Vue Motion V12 may display cine image frames out of sequence

    Philips is recalling Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.

    Product
    Vue Motion V12. Product Number: 1017979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2026·2026-04-08

    Burlington Medical thyroid shields may lose radiation attenuation over time

    Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.

    Product
    Burlington Medical, Thyroid Shield.
    Category
    Medical Device
    Distribution
    Distributed nationwide