Browse Device Recalls
1,169 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,169 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 1,169 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 1, 2025 | Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Gener... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 11, 2025 | Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Num... | Medline has identified a limited quantity of saline IV flush syringes that may not meet the requi... | Class II | Medline Industries, LP |
| Sep 10, 2025 | Medline Adult Anesthesia Set, REF DYNJ39985G | Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due t... | Class II | Medline Industries, LP |
| Aug 21, 2025 | Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-... | The kits contain certain lots of cannula products where the catheter may not retain its shape. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 25, 2025 | Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
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.