Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 27, 2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | X-Ray generator may malfunction resulting in the X-Ray being inoperable. | Class II | Micro-X Ltd. |
| Mar 25, 2026 | Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 | Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 secon... | Class II | Remel Europe Ltd. |
| Mar 19, 2026 | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (I... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 10, 2026 | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US | An internal component of the actuators in a certain production batch may not meet the required me... | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Feb 20, 2026 | Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL... | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Class II | Clariance-SAS |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 3, 2026 | IBA Proton Therapy System - PROTEUS 235 | It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S... | Class II | Ion Beam Applications S.A. |
| Jan 30, 2026 | DxC 700 AU, REF: B86444, B86446 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 30, 2026 | CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 27, 2026 | CLARITY II Laser System; Model No. 1110200210. | Reports of devices sparking/popping and potentially burning patients. | Class II | Lutronic Corporation |
| Jan 26, 2026 | Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 21, 2026 | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism wer... | Class II | Staar Surgical AG |
| Jan 15, 2026 | MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 | Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or ca... | Class II | KOB GmbH |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/16; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/09; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2836/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2835/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8030/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 9, 2026 | Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; | Internal investigations have identified an issue with the durability of the connecting cable near... | Class II | Maquet Cardiopulmonary Gmbh |
| Jan 9, 2026 | Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca... | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Class II | Medartis AG |
| Jan 9, 2026 | Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca... | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Class II | Medartis AG |
| Jan 5, 2026 | Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI... | Due to a modification by a vendor and may be reinstalled without properly engaging the outside re... | Class II | Raz Design Inc |
| Dec 19, 2025 | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemol... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 19, 2025 | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococ... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 19, 2025 | Clearest Strep-A Cassette Test. Test to determine the presence of group A str... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 18, 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly... | Class II | Vascutek, Ltd. |
| Dec 17, 2025 | Genesis Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Dual Thread Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Max Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Hybrid Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Biocomposite Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Push-In Suture Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.