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 301 - 325 of 2,579 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
FDA Z-0015-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-3274-2026
Medical Device High
Oct 7, 2026 Recall: Aug 20, 2026
Details
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; 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-3315-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; 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-3312-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
FDA Z-0053-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0016-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
FDA Z-3293-2026
Medical Device High
Oct 7, 2026 Recall: Aug 10, 2026
Details
FDA Z-0049-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
FDA Z-3275-2026
Medical Device High
Oct 7, 2026 Recall: Aug 20, 2026
Details
FDA Z-0057-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0017-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0050-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-3326-2026
Medical Device High
Oct 7, 2026 Recall: Jun 25, 2026
Details
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
FDA Z-3299-2026
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with 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-3323-2026
Medical Device High
Oct 7, 2026 Recall: Aug 18, 2026
Details
FDA Z-0062-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0026-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0043-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
FDA Z-0068-2027
Medical Device High
Oct 7, 2026 Recall: Sep 17, 2024
Details
FDA Z-0036-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
In-Line Valve, Product Number: P5-TEE
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-3320-2026
Medical Device High
Oct 7, 2026 Recall: Aug 18, 2026
Details
FDA Z-0052-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0027-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
FDA Z-0051-2027
Medical Device High
Oct 7, 2026 Recall: Aug 24, 2026
Details
Upgrade dStream; Model number (REF): 782127; 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-3316-2026
Medical Device High
Oct 7, 2026 Recall: Aug 28, 2026
Details
Showing 301 - 325 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.