Drugs & medicalClass II

Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product…

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Read the official notice →
Date
2025-09-17
Country
United States
Brand
Encore Medical
Product
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product…
Classification
Class II
Units
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Encore Medical recalls

  1. 2026-07-15
  2. US
    Drugs & medicalClass II

    Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis…

    Due to packaging discrepancy with incorrect product size mixed up.

    FDA · DeviceEncore Medical, LPGL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057…Official notice →
  3. 2026-03-04
  4. US
    Drugs & medicalClass II

    Encore Medical, LP recalls Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number:…

    Knee and Humeral socket implants contain incorrect labeling.

    FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT,…Official notice →
  5. 2026-02-11
  6. US
    Drugs & medicalClass II

    Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

    942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay…

    FDA · DeviceEncore Medical, LPUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CAOfficial notice →
  7. 2025-08-20
  8. US
    Drugs & medicalClass II

    Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product…

    Knee implants contain incorrect labeling (size and/or side incorrect)

    FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN,…Official notice →
  9. 2025-07-30
  10. US
    Drugs & medicalClass II

    Encore Medical, LP recalls Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number:…

    Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

    FDA · DeviceEncore Medical, LPRFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular,…Official notice →
  11. 2025-07-23
  12. US
    Drugs & medicalClass II

    Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711…

    Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

    FDA · DeviceEncore Medical, LPU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK,…Official notice →
All 22 Encore Medical recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-17
  2. US
    Drugs & medicalClass II

    Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…

    Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.

    FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…Official notice →
  3. US
    Drugs & medicalClass II

    Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software…

    Measles IgM Test Kit lacks premarket approval or clearance.

    FDA · DeviceQuest International, Inc.US Nationwide distribution in the states of Utah, Texas, and Arizona.Official notice →
  4. US
    Drugs & medicalClass II

    Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02,…

    Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

    FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and the countries of Canada, France, Germany and…Official notice →
  5. US
    Drugs & medicalClass II

    Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

    Dipstick strep A test has potential for false positive results.

    FDA · DeviceQuidel CorporationWorldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC,…Official notice →
  6. US
    Drugs & medicalClass II

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

    Replacement of the internal Sample Pump due to high failure rates.

    FDA · DeviceNOXBOX LTDUS Nationwide distribution in the state of TN.Official notice →
  7. US
    Drugs & medicalClass II

    Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.

    Software issue that results in the display of outdated information.

    FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of GA, NC & TX.Official notice →
See all drugs & medical recalls →