The Recall Desk

State

Guam product recalls

72,940 recalls have nationwide distribution and so reach Guam. 385 additional recalls listed Guam specifically in their distribution scope.

What the numbers show

Total
385
Critical
14
Severe
37
Most recent
2026-01-28

Of the 385 recalls naming Guam we have scored against our rubric, 14 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (10%) are Severe.

These figures cover only the 385 recalls whose distribution notice names Guam specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4976–5000 of 73325

  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2026·2025-10-08

    Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2026·2025-10-08

    Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2026·2025-10-08

    Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches

    Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2026·2025-10-08

    Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2025·2025-10-08

    Junctional tourniquet devices recalled over manufacturing defect affecting structural integrity

    North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.

    Product
    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2026·2025-10-08

    Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches

    Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2026·2025-10-08

    Dental implants recalled after import under non compliant temperature and storage conditions

    S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.

    Product
    IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2026·2025-10-08

    Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2025·2025-10-08

    Ophthalmic imaging software recalled over measured areas smaller than actual values

    MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.

    Product
    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2026·2025-10-08

    Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2026·2025-10-08

    Allura Xper FD20 Biplane OR Table systems recalled for BIOS battery failure

    Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2026·2025-10-08

    Allura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2025·2025-10-08

    Vein ablation generators recalled over software falsely flagging working catheters

    BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.

    Product
    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2026·2025-10-08

    Allura Xper FD20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2026·2025-10-08

    Allura Xper CV20 X-ray systems recalled after BIOS battery halts startup

    Philips is recalling 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.

    Product
    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0011-2026·2025-10-08

    Allura Xper FD20/15 OR Table systems recalled over BIOS battery depletion

    Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.

    Product
    Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2026·2025-10-08

    Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2026·2025-10-08

    Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2026·2025-10-08

    Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion

    Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide