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.
Read the official notice →- Date
- 2026-03-04
- Country
- United States
- Brand
- Encore Medical
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number:…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Encore Medical recalls
- 2026-07-15
USEncore 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 →- 2026-02-11
- US
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 → - 2025-09-17
- US
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.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL,…Official notice → - 2025-08-20
- US
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 → - 2025-07-30
- US
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 → - 2025-07-23
- US
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 →
Other drugs & medical recalls in the United States
- 2026-03-04
- US
Agiliti Health - Ellis recalls Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt…
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10…
- US
Medline Industries, LP recalls Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified…
- US
Edermy LLC recalls PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
FDA · DeviceEdermy LLCUS Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- US
Olympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
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MRIMed Inc. recalls MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam…
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
FDA · DeviceMRIMed Inc.Worldwide - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA,…Official notice →