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.

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.

4576–4600 of 76030

  • HighFDA (Devices)·Z-0328-2026·2025-11-05

    Single unit bag spikes recalled over port weld separation risk

    ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ChemoLock Bag Spike, 01 units REF: CL-10-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2026·2025-11-05

    Infusion line packs recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2026·2025-11-05

    Medication dispensing stations recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 2,755 BD Pyxis MedFlex units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2026·2025-11-05

    Clave bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2026·2025-11-05

    Purple cap administration sets recalled over port weld separation risk

    ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.

    Product
    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0338-2026·2025-11-05

    Anti-siphon smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2026·2025-11-05

    Soft tissue markers recalled over potential contamination with cotton fibers

    Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2026·2025-11-05

    20mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2026·2025-11-05

    Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2026·2025-11-05

    Cardiac control material recalled over vial to vial troponin variability

    Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

    Product
    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2026·2025-11-05

    Coated and nude regular tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular Tampons and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2026·2025-11-05

    Initiation coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2026·2025-11-05

    Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2026·2025-11-05

    Coated and nude regular tampons recalled because product lacks 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2026·2025-11-05

    Refill three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2026·2025-11-05

    Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2026·2025-11-05

    Ophthalmic knife suction sets recalled over residue on internal springs

    MicroSurgical Technology is recalling eight MST ArcDUO 9mm ophthalmic knives because springs in the accompanying suction set carry an unidentified residue that may cause eye irritation.

    Product
    MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2026·2025-11-05

    Initiation coated and nude regular tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2026·2025-11-05

    Coagulation blood tubes recalled over a misplaced label shifting the fill mark

    Greiner Bio-One is recalling 504,000 VACUETTE 2 ml coagulation tubes because the label was applied too high, shifting the printed fill level mark upward.

    Product
    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2026·2025-11-05

    Everolimus 7.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 1,866 cartons of Everolimus tablets 7.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2026·2025-11-05

    Initiation 36 coated super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide