Class IIOngoingZ-1052-2025
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Karl Storz EndoscopyCAFeb 5, 2025
Recalls: Labeling Change Control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–69 of 69 recalls
Class IIOngoingZ-1051-2025
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Karl Storz EndoscopyCAFeb 5, 2025
Class IIOngoingZ-0979-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025
Class IIOngoingZ-0978-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025
Class IIOngoingZ-0977-2025
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences C…NJJan 29, 2025
Class IIOngoingZ-0955-2025
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
IsoTis OrthoBiologics,…CAJan 22, 2025
Class IIIOngoingZ-0805-2025
Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2.…
Qualigen IncCAJan 15, 2025
Class IIOngoingZ-0766-2025
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXJan 1, 2025
Class IIOngoingZ-0761-2025
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXJan 1, 2025