Class IOngoingZ-1568-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 2.4mm
Probes may rupture/burst during activation
Erbe USA IncGAApr 1, 2026
Recalls in Georgia
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 95 recalls
Class IOngoingZ-1567-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 1.7mm
Probes may rupture/burst during activation
Erbe USA IncGAApr 1, 2026
Class IOngoingZ-1566-2026
Erbe USA Inc recalls Flexible Cryoprobe (OD 1.1mm
Probes may rupture/burst during activation
Erbe USA IncGAApr 1, 2026
Class IIOngoingZ-1581-2026
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion L…
Due to adapter not being properly aligned or locked in place.
Elekta, Inc.GAMar 25, 2026
Class IIOngoingZ-1556-2026
International Life Sciences recalls Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm…
Augmentation devices failed bacterial endotoxin testing.
International Life Sci…GAMar 18, 2026
Class IIOngoingZ-1555-2026
International Life Sciences recalls Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
International Life Sci…GAMar 18, 2026
Class IIOngoingZ-1554-2026
International Life Sciences recalls Artelon FlexBand Dynamic Matrix Ref: 31057
Augmentation devices failed bacterial endotoxin testing.
International Life Sci…GAMar 18, 2026
Class IIOngoingZ-1462-2026
Edermy LLC recalls PIE PAK Models: P2HC-A
Lack of 510K clearance
Edermy LLCGAMar 4, 2026
Class IIOngoingZ-1461-2026
Edermy LLC recalls PIE Trolley System Model: 2005
Lack of 510K clearance
Edermy LLCGAMar 4, 2026
Class IIOngoingZ-1340-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1339-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1164-2026
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy
Due to a manufacturing issue and electrical grounding of systems.
Elekta, Inc.GAFeb 4, 2026