Browse Device Recalls
2,945 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,945 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 2,945 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 15, 2024 | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 80... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalo... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version:... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 806... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Philips Azurion Interventional Fluoroscopic X-ray System with Software Versio... | Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 11, 2024 | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... | Class II | Medtronic Inc. |
| Jul 10, 2024 | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... | Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent r... | Class II | Beckman Coulter Mishima K.K. |
| Jul 9, 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 8, 2024 | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Softwar... | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime | Class II | Ion Beam Applications S.A. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B-Intended to be used as a diag... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with AXIOM Se... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with Sensis Hi... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x ent... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 28, 2024 | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x enti... | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... | Class II | Philips North America Llc |
| Jun 27, 2024 | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/60... | If temperature management system fails to reach correct target water temperature while device is ... | Class II | Medivance Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I | Medtronic Xomed, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
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.