Class III medical devices recalls

FDA Class III recalls of medical devices, newest first. Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

138 recalls published between October 23, 2024 and August 26, 2026. Most common issues: mislabeling (4), software (3), electrical shock (2), sterility (1).

• Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model recall
  FDA August 26, 2026 · Paragon 28, Inc. · Class III
• Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model recall
  FDA August 26, 2026 · Paragon 28, Inc. · Class III
• Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN… recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• Heraeus, PALAMIX duo recall
  FDA May 6, 2026 · Heraeus Medical GmbH (Dental Division) · Class III
• Heraeus, PALAMIX uno recall
  FDA May 6, 2026 · Heraeus Medical GmbH (Dental Division) · Class III
• Philips X7-2 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips X3-1 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips S5-2 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips S4-1 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips OMNI III TEE Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips OMNI II TEE Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips Mini Multi TEE Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips L17-5 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips L12-5 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips C9-4 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Philips 3D6-2 Ultrasound Transducer recall
  FDA April 1, 2026 · Philips Ultrasound, Inc · Class III
• Battery Charging Station recall
  FDA March 25, 2026 · Datascope Corp. · Class III
• Penner Pacific Bathing Spa, Model Numbers 860010-1L recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L… recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA… recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE… recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 360020-1P recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 360020-1EP recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W… recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X recall
  FDA March 18, 2026 · Penner Patient Care, Inc. · Class III
• Surepulse VS Cap Extra Large recall
  FDA February 18, 2026 · Surepulse Medical Ltd · Class III
• Surepulse VS Cap Large recall
  FDA February 18, 2026 · Surepulse Medical Ltd · Class III
• Surepulse VS Cap Medium recall
  FDA February 18, 2026 · Surepulse Medical Ltd · Class III
• Surepulse VS Cap Small recall
  FDA February 18, 2026 · Surepulse Medical Ltd · Class III
• Surepulse VS Cap Extra Small recall
  FDA February 18, 2026 · Surepulse Medical Ltd · Class III
• WB Impression Post Closed Tray incl recall
  FDA February 18, 2026 · Straumann USA LLC · Class III
• HemosIL SynthAFax recall
  FDA December 24, 2025 · Instrumentation Laboratory · Class III
• Cardiosave Rescue recall
  FDA December 24, 2025 · Datascope Corp. · Class III
• Cardiosave Hybrid recall
  FDA December 24, 2025 · Datascope Corp. · Class III
• CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer… recall
  FDA December 17, 2025 · Orthofix U.S. LLC · Class III
• OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control… recall
  FDA November 26, 2025 · Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC · Class III
• VerifyNow PRUTest Platelet Reactivity Test recall
  FDA November 19, 2025 · Accriva Diagnostics, Inc. · Class III
• One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g… recall
  FDA October 29, 2025 · Home Health US, Incorporated · Class III
• FloPatch FP120 recall
  FDA September 10, 2025 · Flosonics Medical (R/A 1929803 ONTARIO CORP.) · Class III
• Akreos, SKU: AO60P0300. Akreos intraocular lenses recall
  FDA September 3, 2025 · Bausch & Lomb Surgical, Inc. · Class III
• XL14-3 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X8-2t Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X7-2t Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X7-2 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X6-1 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X5-1c Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X5-1 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X3-1 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• X11-4t Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• VL13-5 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• V9-2 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III
• V6-2 Transducer Probe recall
  FDA September 3, 2025 · Philips Ultrasound, Inc · Class III