Heraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl…
Potential for monomer liquid leakage.
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- Heraeus Medical
- Product
- PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Aland Islands,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Heraeus Medical recalls
- 2026-05-06
USHeraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce…
FDA · DeviceHeraeus Medical GmbH (Dental Division)Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice →- 2026-01-21
- US
Heraeus Medical GmbH (Dental Division) recalls Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software…
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of…
FDA · DeviceHeraeus Medical GmbH (Dental Division)International distribution in the countries of Aland Islands, Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-07
- US
Philips North America recalls Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software…
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction…
FDA · DevicePhilips North AmericaWorldwide distribution - Nationwide and the countries of Algeria, Argentina,…Official notice → - US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
- US
Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe…
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of CA, GA and the…Official notice → - US
Olympus Corporation of the Americas recalls Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice → - US
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2)…
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user…
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.Official notice → - US
American Contract Systems Inc recalls Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989…
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to…
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and…Official notice →