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.

5101–5125 of 76030

  • HighFDA (Devices)·Z-2601-2025·2025-10-01

    IQon Spectral CT recalled over ball screw misalignment lowering the couch

    Philips IQon Spectral CT systems, model 728332, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 81 units are affected.

    Product
    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2025·2025-10-01

    Allura Xper FD20/15 OR Table recalled over internal component deterioration

    The Philips Allura Xper FD20/15 OR Table is recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. One unit is affected.

    Product
    Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2025·2025-10-01

    Sofmed Breathables contact lenses recalled over an invalid sterilization cycle

    Sofmed Breathables contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 180 units are affected.

    Product
    Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2025·2025-10-01

    Patient monitors recalled over potential activation of an abnormal alarm pause

    BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.

    Product
    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2025·2025-10-01

    Brilliance CT 40 and 64 channel systems recalled over unexpected couch descent

    Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2025·2025-10-01

    Brilliance 16 and 6 slice scanners recalled over patient table descent

    Philips Brilliance 16 Power, Brilliance CT 16 Slice and Brilliance CT 6 Slice systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 73 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2615-2025·2025-10-01

    Orthopedic inserter adapters recalled over weld breakage between pin and holder

    Ortoma Inserter Adapter OTD devices are recalled because of a weld breakage between the pin and the inserter holder. 261 devices are affected.

    Product
    Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2025·2025-10-01

    Allura Xper FD20 Biplane OR Table recalled over internal component deterioration

    Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.

    Product
    Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2025·2025-10-01

    Ingenuity CT scanners recalled because the patient couch may descend unexpectedly

    Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2025·2025-10-01

    Brilliance iCT systems recalled over ball screw misalignment dropping the couch

    Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2025·2025-10-01

    Allura Xper FD20 Biplane recalled over component deterioration affecting motorized movements

    Philips Allura Xper FD20 Biplane systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 268 units are affected.

    Product
    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2025·2025-10-01

    Big Bore CT systems recalled because patient table may descend unexpectedly

    Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V658000·2025-10-01

    2026 Tesla Model Y: Reverse Lights May Fail to Illuminate

    Tesla is recalling certain 2026 Model Y vehicles because the reverse lights may fail to illuminate due to a wiring defect, which could reduce visibility when backing and increase crash risk.

    Product
    TESLA — TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2025·2025-10-01

    Intravenous solution sets recalled after customer reports of tubing separation

    Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.

    Product
    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2025·2025-10-01

    Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration

    Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.

    Product
    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2025·2025-10-01

    Allura CV20 systems recalled over internal component deterioration disabling motorized movement

    Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.

    Product
    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2025·2025-10-01

    MyDay toric contact lenses recalled after one lot used invalid sterilization

    MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.

    Product
    MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2025·2025-10-01

    Philips CT Systems Patient Support Table May Descend Unexpectedly

    Philips is recalling certain CT systems because the patient support table may descend unexpectedly to the lowest position due to a component misalignment during replacement.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2025·2025-10-01

    Allura Xper FD20/20 systems recalled over battery, drive and power supply deterioration

    Philips Allura Xper FD20/20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 75 units are affected.

    Product
    Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2025·2025-10-01

    Soft tissue anchors recalled after cartons packed with wrong device size

    Zimmer Biomet is recalling JuggerKnot Mini Soft Anchors after outer cartons labeled for the 1.0mm Mini product were found to contain 1.4mm Short devices instead.

    Product
    Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration

    Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2025·2025-10-01

    Surgical light systems recalled over powder coating stress lines and chipping

    Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.

    Product
    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0671-2025·2025-10-01

    Amphetamine extended-release capsules 15 mg recalled after impurity testing failure

    Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0672-2025·2025-10-01

    Amphetamine extended-release capsules 20 mg recalled over impurity and degradation results

    Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide