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.

4526–4550 of 76030

  • HighFDA (Devices)·Z-0325-2026·2025-11-05

    BrainSTORM surgical planner recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2026·2025-11-05

    Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2026·2025-11-05

    ChemoLock ports with Spiros recalled over port weld separation risk

    ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2026·2025-11-05

    Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2026·2025-11-05

    Augmented reality spine platform recalled over image layer misalignment in fusion

    Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.

    Product
    SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2026·2025-11-05

    Endoscopic navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2026·2025-11-05

    13mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2026·2025-11-05

    Graduated connectors recalled because port weld may separate and leak

    ICU Medical is recalling 1,700 Graduated Connectors with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2026·2025-11-05

    Desipramine 25 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2026·2025-11-05

    Trocar sealing units with reducer recalled over detaching silicone fragments

    Aesculap is recalling 26 sealing units for 10/12mm trocars with reducer because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 14,329 sterile Testosterone Regular Release 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2026·2025-11-05

    Compounded pain injection syringes recalled over presence of particulate matter

    QuVa Pharma is recalling 75,885 syringes of its R.E.C.K. periarticular injection over the presence of particulate matter.

    Product
    R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 4,929 sterile Testosterone 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2026·2025-11-05

    Surgical console accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling six 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' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2026·2025-11-05

    Chemotherapy administration sets recalled because port weld may separate and leak

    ICU Medical is recalling 7,950 20-drop administration sets with an integrated ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2026·2025-11-05

    Oncology kits with vented vial spike recalled over port weld failure

    ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break and leak.

    Product
    ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2026·2025-11-05

    Magseed Pro 12 cm markers recalled over potential cotton fiber contamination

    Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. 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-0351-2026·2025-11-05

    21 inch extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2026·2025-11-05

    Testosterone and triamcinolone 87.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 21,324 sterile Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2026·2025-11-05

    ChemosafeLock connectors recalled because port weld may break and leak

    ICU Medical is recalling 134,700 ChemosafeLock Connectors because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Connecter REF: KL-FNU3
    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-0377-2026·2025-11-05

    Brazil market CT scanner recalled over six software faults affecting movement

    Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • 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-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 (Drugs)·D-0104-2026·2025-11-05

    Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide