Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Due to incorrect functional length on device labeling.

Date

2026-06-10

Country

United States

Brand

Grace Medical, Inc.

Product

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Classification

Class II

Units

U.S Nationwide distribution in the state of MD.

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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

1. 2026-06-17
2. US
   Drugs & medicalClass I

   SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for:…

   Presence of Particulate matter: Particulate matter identified as glass.

   FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCU.S. NationwideOfficial notice →
3. 2026-06-10
4. US
   Drugs & medicalClass II

   Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description:…

   Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic…

   FDA · DeviceIntuitive Surgical, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice →
5. US
   Drugs & medicalClass II

   SSC- Surgical Specialties Corporation recalls Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

   3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

   FDA · DeviceSSC- Surgical Specialties CorporationWorldwide - US Nationwide distribution in the states of Texas, Utah, Michigan…Official notice →
6. US
   Drugs & medicalClass II

   Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX

   Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

   FDA · DeviceWindstone Medical Packaging, Inc.US Nationwide distribution in the states of IL, VA.Official notice →
7. US
   Drugs & medicalClass II

   GE Medical Systems China Co., Ltd. recalls MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

   Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical…

   FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide - US Nationwide distribution in the states of Florida and Georgia.…Official notice →
8. US
   Drugs & medicalClass II

   DeRoyal Industries Inc recalls DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

   Sterile wound dressing, lacks sterility assurance

   FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of FL & NC.Official notice →