The Recall Desk

Manufacturer

Heraeus Medical GmbH (Dental Division)

6 recalls in our database name Heraeus Medical GmbH (Dental Division) as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-05-06

Of the 6 recalls from Heraeus Medical GmbH (Dental Division) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • LowFDA (Devices)·Z-1997-2026·2026-05-06

    Heraeus PALAMIX uno Dental Material Mixing Rod Loose Risk Recall

    Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.

    Product
    Heraeus, PALAMIX uno. Material Number: 66057893.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1998-2026·2026-05-06

    Heraeus PALAMIX duo dental mixing system batches worldwide recall

    Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.

    Product
    Heraeus, PALAMIX duo. Material Number: 66057897.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2026·2026-01-21

    Swan rubbing alcohol recalled over insanitary conditions at a distribution center

    Gold Star Distribution is recalling Swan White Clear Alcohol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

    Product
    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1080-2026·2026-01-21

    PALACOS R bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS R pro 40 and PALACOS R pro 80 bone cement because a combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable fo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1081-2026·2026-01-21

    PALACOS R plus G bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1083-2026·2026-01-21

    Procedure kits recalled over suction irrigators that can leak during use

    Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable
    Category
    Medical Device
    Distribution
    0 states