Browse Device Recalls
3,415 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,415 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 3,415 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 10, 2025 | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for c... | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Draeger, Inc. |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbi... | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious... | Class I | Fresenius Kabi USA, LLC |
| Oct 30, 2025 | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Mod... | Potential that the ligation loop was unable to release or detach as expected during use, causing ... | Class I | Olympus Corporation of the Americas |
| Oct 17, 2025 | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF... | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, wh... | Class I | CareFusion 303, Inc. |
| Oct 13, 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | Class I | TMJ Solutions Inc |
| 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 9, 2025 | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914;... | The impacted lot may not meet the required tensile strength specification. | Class I | Glycar SA Pty., Ltd. |
| Oct 9, 2025 | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510... | The impacted lot may not meet the required tensile strength specification. | Class I | Glycar SA Pty., Ltd. |
| Oct 6, 2025 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... | Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... | Class I | Tandem Diabetes Care, Inc. |
| Oct 2, 2025 | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w... | IV Gravity burette administration set burette component is missing an internal shutoff valve inte... | Class I | ICU Medical, Inc. |
| Oct 2, 2025 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UN... | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke... | Class I | Cerenovus Inc |
| Oct 1, 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | There is a potential for an ice blockage to form or currently exist within the primary and/or the... | Class I | Siemens Medical Solutions USA, Inc |
| Oct 1, 2025 | Automated Impella Controller (AIC), used for left heart support blood pump, l... | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella ... | Class I | Abiomed, Inc. |
| Sep 30, 2025 | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET F... | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damag... | Class I | B BRAUN MEDICAL INC |
| Sep 30, 2025 | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesl... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siem... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 26, 2025 | CODMAN Disposable Perforator 9mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 26, 2025 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... | Due to an identified manufacturing defect involving coating material lifting within the catheter'... | Class I | BALT USA, LLC |
| Sep 18, 2025 | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... | Class I | Cook Medical Incorporated |
| Sep 17, 2025 | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: ... | IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't us... | Class I | Percussionaire Corporation |
| Sep 16, 2025 | Automated Impella Controller (AIC) labeled as the following with correspondin... | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... | Class I | Abiomed, Inc. |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
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.