Z-0225-2023 Class II Ongoing
FDA device recall Z-0225-2023 was initiated by Boston Scientific Corporation on Oct 10, 2022 and is designated Class II. Reason for recall: ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post… The recall status is ongoing. Affected quantity: 402,968 Total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Oct 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 402,968 Total
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Israel Italy Jordan Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands New Zealand Norway Oman Palestine Panama Per¿ Poland Portugal Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Unit.Arab Emir. Zimbabwe
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0225-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026