Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-10-22FDA-DeviceOlympus Corporation of the AmericasClass IEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-10-22FDA-DeviceOlympus Corporation of the AmericasClass IBRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-10-22FDA-DeviceOlympus Corporation of the AmericasClass IOES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-10-22FDA-DeviceOlympus Corporation of the AmericasClass IEVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-10-22FDA-DeviceOlympus Corporation of the AmericasClass IBRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-10-22FDA-DeviceCook Medical IncorporatedClass IZenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
- 2025-10-22FDA-DevicePercussionaire CorporationClass IPhasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
- 2025-10-15FDA-DeviceApplied Medical Technology IncClass IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
- 2025-10-15FDA-DeviceApplied Medical Technology IncClass IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
- 2025-10-15FDA-DeviceApplied Medical Technology IncClass IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
- 2025-10-15FDA-DeviceApplied Medical Technology IncClass IINutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIDesign Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IICombined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIDesign Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREI
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IICombined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA TUOHY 19GA SPRW OT.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceB BRAUN MEDICAL INCClass IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
Potential for the lid of the catheter connector to be in the incorrect position.
- 2025-10-15FDA-DeviceInpeco S.A.Class IIFlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
- 2025-10-15FDA-DeviceInpeco S.A.Class IIFlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
- 2025-10-15FDA-DeviceLeMaitre Vascular, Inc.Class IIArtegraft 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 replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
- 2025-10-15FDA-DeviceBeckman Coulter Inc.Class IISYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
- 2025-10-15FDA-DeviceAbiomed, Inc.Class IAutomated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controll
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
- 2025-10-15FDA-DeviceGE Medical Systems, SCSClass IIAW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief