Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 3,201–3,250 of 8,689

• Medical Device Recall · August 25, 2025

  LeMaitre Vascular, Inc.

  Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or repla

  Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable W

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  Sonesta Medical AB

  Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the u

  Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Dai

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  CooperVision, Inc.

  MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Bli

  One lot manufactured with an invalid sterilization cycle.

  Class II

• Medical Device Recall · August 22, 2025

  GE Medical Systems, LLC

  MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

  If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Medline Industries, LP

  Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

  The kits contain certain lots of cannula products where the catheter may not retain its shape.

  Class I

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT CG4+ cartridge (white). List Number: 03P85-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Bard Peripheral Vascular Inc

  Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop

  Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT EG6+ cartridge. List Number: 03P77-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 21, 2025

  Folsom Metal Products, Inc.

  Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

  Labeling includes shelf life that has not been validated.

  Class II

• Medical Device Recall · August 21, 2025

  Abbott Point Of Care Inc.

  i-STAT EG7+ cartridge. List Number: 03P76-25.

  Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L111, ESSENTIO DR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U226, VISIONIST CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Abiomed, Inc.

  Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Pack

  Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR SL (Model L301)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L121 ESSENTIO DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR EL (Model L321)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L209 PROPONENT DR (VDD) SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U125, VALITUDE CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L211 PROPONENT DR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR EL MRI (Model L331)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L110, ESSENTIO SR SL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U228, VISIONIST CRT-P EL MRI

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S701 ALTRUA 2 SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  MicroSurgical Technology Inc

  MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

  An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

  Class II

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE SR SL MRI (Model L310)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE SR SL (Model L300)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L100, ESSENTIO SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S722, ALTRUA 2 DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number S702, ALTRUA 2 DR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  PROPONENT DR SL (Model L201)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  ACCOLADE DR SL MRI (Model L311)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L231, PROPONENT DR EL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  PROPONENT SR SL (Model L200)

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L221 PROPONENT DR EL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L131, ESSENTIO DR EL MRI Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U225 VISIONIST CRT-P EL

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L210 PROPONENT SR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number U128, VALITUDE CRT-P EL MRI

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 20, 2025

  Boston Scientific Corporation

  Model Number L101, ESSENTIO DR SL Pacemaker

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

  Class I

• Medical Device Recall · August 19, 2025

  Greiner Bio-One North America, Inc.

  Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Sepa

  Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

  Class II

• Medical Device Recall · August 18, 2025

  CORNEAT VISION, LTD.

  CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

  Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

  Class II

• Medical Device Recall · August 18, 2025

  Boston Scientific Corporation

  Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

  Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

  Class II