Browse Device Recalls
34,608 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,608 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 34,608 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 23, 2026 | Pelvic Reconstruction System (PRS) with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Volar Radius Plate with Angular Stability with the following description: Rad... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Pilonplate with Angular Stability, with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | FR.O.H. Calcaneus Repair System with the following description: Anterolateral... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) Syst... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Brand Name: Humeral Head Plate with Angular Stability, with the following des... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Claviculaplate with Angular Stability, with the below descriptions and associ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Fibula Plate PROlock with Angular Stability with the below description... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. LRS (Locking Reconstruction System) with the below descriptions and co... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with t... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Straight Plate with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Distal Humeral Plates with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | HLS - Hand Locking Plates System with the below descriptions and correspondin... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Screw System with the below descriptions and corresponding article num... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Olecranonplate with Angular Stability with the below descriptions and corresp... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate wit... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulat... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | CS100 IABP. Software Version CS100 IABP Q.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Jan 23, 2026 | CS300 IABP. Software Version CS300 IABP C.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Jan 21, 2026 | Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt sup... | Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Li... | Class II | Agiliti Health - Ellis |
| Jan 21, 2026 | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet... | Class II | Stryker Corporation |
| Jan 21, 2026 | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog ... | Due to pediatric defibrillator electrode delamination | Class II | Physio-Control, Inc. |
| 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 21, 2026 | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-0... | Device for bronchoscopic visualization, patient airway access has software issue: if application ... | Class II | Auris Health, Inc |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407504. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445010 & 00055445011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055415004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No: 00055415011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 20, 2026 | cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl... | Class II | Roche Diagnostics Operations, Inc. |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407510. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407508. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407511. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
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.