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 101 - 125 of 1,678 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
FDA Z-2670-2026
Medical Device High
Jul 8, 2026 Recall: Feb 20, 2026
Details
FDA Z-2542-2026
Medical Device High
Jul 8, 2026 Recall: May 21, 2026
Details
FDA Z-2639-2026
Medical Device High
Jul 8, 2026 Recall: May 7, 2026
Details
CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
FDA Z-2629-2026
Medical Device High
Jul 8, 2026 Recall: May 21, 2026
Details
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
FDA Z-2607-2026
Medical Device High
Jul 8, 2026 Recall: May 28, 2026
Details
FDA Z-2656-2026
Medical Device High
Jul 8, 2026 Recall: May 21, 2026
Details
RayCare 2024A SP1. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
FDA Z-2646-2026
Medical Device High
Jul 8, 2026 Recall: May 20, 2026
Details
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
FDA Z-2609-2026
Medical Device High
Jul 8, 2026 Recall: May 28, 2026
Details
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA Z-2623-2026
Medical Device High
Jul 8, 2026 Recall: Jun 3, 2026
Details
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
FDA Z-2579-2026
Medical Device High
Jul 1, 2026 Recall: Jun 5, 2026
Details
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA Z-2529-2026
Medical Device High
Jul 1, 2026 Recall: May 20, 2026
Details
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2571-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2563-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA Z-2527-2026
Medical Device High
Jul 1, 2026 Recall: May 20, 2026
Details
FDA Z-2532-2026
Medical Device High
Jul 1, 2026 Recall: May 28, 2026
Details
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA Z-2530-2026
Medical Device High
Jul 1, 2026 Recall: May 20, 2026
Details
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA Z-2596-2026
Medical Device High
Jul 1, 2026 Recall: Feb 27, 2026
Details
FDA Z-2583-2026
Medical Device High
Jul 1, 2026 Recall: Feb 27, 2026
Details
FDA Z-2593-2026
Medical Device High
Jul 1, 2026 Recall: Feb 27, 2026
Details
FDA Z-2602-2026
Medical Device High
Jul 1, 2026 Recall: May 22, 2026
Details
FDA Z-2586-2026
Medical Device High
Jul 1, 2026 Recall: Feb 27, 2026
Details
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2560-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2567-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2555-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Z-2573-2026
Medical Device High
Jul 1, 2026 Recall: Apr 30, 2026
Details
Showing 101 - 125 of 1,678 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.