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 801 - 825 of 1,678 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
FDA Z-1921-2026
Medical Device High
Apr 29, 2026 Recall: Mar 11, 2026
Details
FDA Z-1889-2026
Medical Device High
Apr 29, 2026 Recall: Feb 27, 2026
Details
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA Z-1908-2026
Medical Device High
Apr 29, 2026 Recall: Mar 25, 2026
Details
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA Z-1845-2026
Medical Device High
Apr 29, 2026 Recall: Feb 25, 2026
Details
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
FDA Z-1895-2026
Medical Device High
Apr 29, 2026 Recall: Mar 13, 2026
Details
FDA Z-1828-2026
Medical Device High
Apr 29, 2026 Recall: Mar 6, 2026
Details
FDA Z-1912-2026
Medical Device High
Apr 29, 2026 Recall: Mar 11, 2026
Details
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA Z-1864-2026
Medical Device High
Apr 29, 2026 Recall: Mar 3, 2026
Details
FDA Z-1882-2026
Medical Device High
Apr 29, 2026 Recall: Feb 27, 2026
Details
FDA Z-1877-2026
Medical Device High
Apr 29, 2026 Recall: Feb 27, 2026
Details
FDA Z-1913-2026
Medical Device High
Apr 29, 2026 Recall: Mar 11, 2026
Details
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA Z-1860-2026
Medical Device High
Apr 29, 2026 Recall: Mar 3, 2026
Details
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
FDA Z-1937-2026
Medical Device High
Apr 29, 2026 Recall: Mar 24, 2026
Details
FDA Z-1887-2026
Medical Device High
Apr 29, 2026 Recall: Feb 27, 2026
Details
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA Z-1858-2026
Medical Device High
Apr 29, 2026 Recall: Mar 3, 2026
Details
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA Z-1841-2026
Medical Device High
Apr 29, 2026 Recall: Feb 25, 2026
Details
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA Z-1902-2026
Medical Device High
Apr 29, 2026 Recall: Mar 25, 2026
Details
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA Z-1830-2026
Medical Device High
Apr 29, 2026 Recall: Feb 25, 2026
Details
FDA Z-1914-2026
Medical Device High
Apr 29, 2026 Recall: Mar 11, 2026
Details
FDA Z-1911-2026
Medical Device High
Apr 29, 2026 Recall: Mar 11, 2026
Details
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA Z-1907-2026
Medical Device High
Apr 29, 2026 Recall: Mar 25, 2026
Details
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA Z-1871-2026
Medical Device High
Apr 29, 2026 Recall: Mar 3, 2026
Details
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Unapproved design changes to the products outside of the 510(k) clearance.
FDA Z-1888-2026
Medical Device High
Apr 29, 2026 Recall: Feb 27, 2026
Details
Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
FDA Z-1922-2026
Medical Device High
Apr 29, 2026 Recall: Mar 16, 2026
Details
FDA Z-1893-2026
Medical Device High
Apr 29, 2026 Recall: Mar 13, 2026
Details
Showing 801 - 825 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.