March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Hazard: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
March 18, 2026Medical DevicesFDA
Exactech, Inc. recalls Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Hazard: Impactor handle may be missing cross-pin
March 18, 2026Medical DevicesFDA
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Hazard: Impactor handle may be missing cross-pin
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 860010-1L
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 3
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 360020-1P
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L,
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Hazard: The device does not bear a unique device identifier.
March 18, 2026Medical DevicesFDA
Raz Design Inc recalls Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (At
Hazard: Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
March 18, 2026Medical DevicesFDA
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235
Hazard: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
March 18, 2026Medical DevicesFDA
Becton Dickinson & Company recalls 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Hazard: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
March 18, 2026Medical DevicesFDA
KOB GmbH recalls MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Hazard: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re
Hazard: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
March 11, 2026Medical DevicesFDA
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Hazard: Behind-the-ear sound processer packaging label is different then included product.
March 11, 2026Medical DevicesFDA
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6
Hazard: Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
March 11, 2026Medical DevicesFDA
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro
Hazard: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.