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 601 - 625 of 2,579 matching product recalls.
Product Recall Search
Product Recall Source Type Risk Date Action
FDA Z-3027-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Test manufactured with an expired ingredient which may present as either a false negative or positive.
FDA Z-3032-2026
Medical Device High
Sep 2, 2026 Recall: Jul 29, 2026
Details
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Kits contain a potentially contaminated component which were recalled by the manufacturer
FDA Z-3021-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Potential of failing to trigger clinical scan during Bolus Tracking.
FDA Z-2988-2026
Medical Device High
Sep 2, 2026 Recall: Jun 26, 2026
Details
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Software issue may cause the ruler measurement to be inaccurate.
FDA Z-3030-2026
Medical Device High
Sep 2, 2026 Recall: Jul 22, 2026
Details
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
FDA Z-3001-2026
Medical Device High
Sep 2, 2026 Recall: Jun 29, 2026
Details
FDA Z-2997-2026
Medical Device High
Sep 2, 2026 Recall: Jul 8, 2026
Details
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
FDA Z-2995-2026
Medical Device High
Sep 2, 2026 Recall: Jul 8, 2026
Details
FDA Z-3020-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA Z-3007-2026
Medical Device High
Sep 2, 2026 Recall: Jul 9, 2026
Details
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
FDA Z-3012-2026
Medical Device High
Sep 2, 2026 Recall: Jul 20, 2026
Details
FDA Z-3025-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
healthmark ProChek-II, Model Number PT-313, PT-201-12
Test manufactured with an expired ingredient which may present as either a false negative or positive.
FDA Z-3031-2026
Medical Device High
Sep 2, 2026 Recall: Jul 29, 2026
Details
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
FDA Z-3018-2026
Medical Device High
Sep 2, 2026 Recall: Jul 14, 2026
Details
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA Z-3008-2026
Medical Device High
Sep 2, 2026 Recall: Jul 9, 2026
Details
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
FDA Z-3039-2026
Medical Device High
Sep 2, 2026 Recall: Jul 20, 2026
Details
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Kits contain a potentially contaminated component which were recalled by the manufacturer
FDA Z-3019-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA Z-3010-2026
Medical Device High
Sep 2, 2026 Recall: Jul 9, 2026
Details
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-0
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
FDA Z-2993-2026
Medical Device High
Sep 2, 2026 Recall: Jul 13, 2026
Details
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA Z-3009-2026
Medical Device High
Sep 2, 2026 Recall: Jul 9, 2026
Details
FDA Z-3015-2026
Medical Device High
Sep 2, 2026 Recall: Jul 9, 2026
Details
FDA Z-2996-2026
Medical Device High
Sep 2, 2026 Recall: Jul 8, 2026
Details
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
FDA Z-3013-2026
Medical Device High
Sep 2, 2026 Recall: Jul 20, 2026
Details
FDA Z-2998-2026
Medical Device High
Sep 2, 2026 Recall: Jul 14, 2026
Details
FDA Z-2999-2026
Medical Device High
Sep 2, 2026 Recall: Jul 10, 2026
Details
Showing 601 - 625 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.