The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1426–1450 of 21588

  • 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-0015-2026·2025-10-08

    Allura Centron cardiovascular X-ray systems recalled over BIOS battery depletion

    Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.

    Product
    Cardio Vascular-Allura Centron; Model Numbers: 722400; 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-0032-2026·2025-10-08

    Clinical chemistry analyzer modules recalled over stalled test status and delays

    Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.

    Product
    DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2640-2025·2025-10-08

    Hip stems recalled over potential mix of two catalog numbers in packaging

    Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.

    Product
    1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0004-2026·2025-10-08

    Allura Xper FD10 OR Table systems recalled over BIOS battery depletion

    Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033; 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
  • ModerateFDA (Devices)·Z-0001-2026·2025-10-08

    Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.

    Product
    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0008-2026·2025-10-08

    Raspberry peach jam cookies recalled for undeclared Red 3 and Blue 1

    Vanilla Cookies with Raspberry Peach Jam are being recalled because the colour additives Red 3 and Blue 1 are not declared on the label. The recall covers 172 cases.

    Product
    Vanilla Cookies with Raspberry Peach Jam
    Category
    Food
    Distribution
    1 state
  • 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-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-0034-2026·2025-10-08

    Collagen vascular grafts recalled over unapproved bovine raw material supplier

    LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.

    Product
    Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2026·2025-10-08

    Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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-0009-2026·2025-10-08

    Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2025·2025-10-08

    Vital sign monitors recalled over blood pressure measurement error messages

    Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.

    Product
    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
    Category
    Medical Device
    Distribution
    Distributed nationwide