Browse Device Recalls
1,001 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,001 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 1,001 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 21, 2025 | Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,... | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occur... | Class II | Medline Industries, LP |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 11, 2025 | DEXLOCK Achilles Repair Implant Kits, MAKT4520 | There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill gu... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NO... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 10, 2025 | Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINO... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT D... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Convenience Kit, BREAST HERNIA DYNJ909125G | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GEN... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 10, 2025 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... | Class I | Medline Industries, LP |
| Oct 3, 2025 | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. | Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit ... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible ... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW V... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with ... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
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.