FDA device recall and safety alerts

Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Search FDA medical device recalls and early alerts for equipment, software, implants, monitors, diagnostic tools and patient-use devices. Match device name, company, recall class, product code, UDI, model, lot and serial details.

Search Medical Device Recalls By Device, Company Or Recall Class

Use this medical device recall search to check FDA device notices by device name, company, product code, lot number, recall class, risk level or correction/removal details.

Medical Device Recall Alerts List

Showing 226 - 250 of 2,579 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
FDA Z-0089-2027
Medical Device High
Oct 14, 2026 Recall: Sep 8, 2026
Details
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA Z-0091-2027
Medical Device High
Oct 14, 2026 Recall: Jul 24, 2026
Details
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.
FDA Z-0087-2027
Medical Device High
Oct 14, 2026 Recall: Aug 14, 2026
Details
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
FDA Z-0078-2027
Medical Device High
Oct 14, 2026 Recall: Aug 21, 2026
Details
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.
FDA Z-0088-2027
Medical Device High
Oct 14, 2026 Recall: Aug 20, 2026
Details
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
FDA Z-0074-2027
Medical Device High
Oct 14, 2026 Recall: Aug 31, 2026
Details
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
FDA Z-0085-2027
Medical Device High
Oct 14, 2026 Recall: Aug 18, 2026
Details
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X); Software Versions: R11, R12 and R13;
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
FDA Z-3314-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
FDA Z-3333-2026
Medical Device High
Oct 7, 2026 Recall: Aug 12, 2026
Details
FDA Z-0041-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0064-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0023-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
FDA Z-3306-2026
Medical Device High
Oct 7, 2026 Recall: Sep 14, 2026
Details
FDA Z-3301-2026
Medical Device High
Oct 7, 2026 Recall: Aug 20, 2026
Details
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
FDA Z-3319-2026
Medical Device High
Oct 7, 2026 Recall: Aug 18, 2026
Details
FDA Z-0048-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0034-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-3273-2026
Medical Device High
Oct 7, 2026 Recall: Aug 20, 2026
Details
FDA Z-0054-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0031-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0030-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Z-3288-2026
Medical Device High
Oct 7, 2026 Recall: Aug 11, 2026
Details
FDA Z-0058-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0024-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0047-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Showing 226 - 250 of 2,579 product recalls

Medical Device Recalls Today

Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.

Search The Device Label

Use the device name, company, product code, UDI, model, catalog number, serial number, lot number, software version or implant card details.

Recall Class And Risk Level

Class I recalls are generally the most serious. Read the FDA notice for patient risk, affected devices, correction/removal steps and clinical action.

What To Check On A Device Label

If the device supports or monitors health, do not stop treatment based only on a search result. Confirm with the official notice and your clinician when needed.

How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Match The Exact Medical device

Use each recall result to compare device name, company, product code, model, serial, lot number, UDI and software version. A similar name is not enough; recalls often apply only to specific versions or production ranges.

Read The Recall Hazard

Check the notice for FDA recall class, patient risk, correction, removal and clinical action. This helps you decide whether the item should be stopped immediately or handled through a normal remedy process.

Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.

Medical Device Recalls: FDA Device Safety Alerts And Recall Notices FAQ

Short answers for checking whether a specific item is included in this recall category.

How do I know if this medical device is recalled?

Search the product name or brand, then compare model, serial, lot, code, date, retailer and official recall number details on the detail page.

What should I do after finding a matching recall?

Stop using the product if the official notice says to do so, keep the label or packaging, and follow the remedy instructions for repair, refund, replacement or disposal.

Why can two similar products have different recall status?

Recalls can be limited to certain production dates, factories, lots, model numbers, colors, sizes, retailers or distribution areas.

Is this page the official recall notice?

No. This page helps you search public recall data. Use the linked agency or company notice as the final source before taking action.