fda regulated Recalls

Navajo Manufacturing Handy Solutions Neck & Shoulders Heating Pad Recalled 28,457 Units (2026)

Mentor Texas Artoura Breast Tissue Expanders Recalled Worldwide in 2026

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Medline Sterile Radiology Procedure Kits Recalled for Sterility Breach (2026)

There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

Abiomed Purge Cassette Recall 2026: 33,107 Impella Pump Sets Worldwide Over Purge Leaks

Increased risk of purge leaks with Generation 1 purge cassettes.

Mentor Artoura Breast Tissue Expanders Recall for Dull Needle Tips (2026)

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Mentor Texas Artoura Breast Tissue Expanders Recalled Worldwide Over Dull Infusion Needle Tips (2026

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Mentor Texas CPX 4 US Breast Tissue Expanders Recall 2026

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Mentor CPX 4 Breast Tissue Expanders Recalled in 2026 for Dull Needle Tip Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Mentor Texas LP Recalls CPX 4 US Breast Tissue Expanders with Suture Tabs (2026)

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Mentor Texas CPX 4 Breast Tissue Expander Recall 2026 for Dull Needle Tips

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Kirkman MAXIMUM Zone 1 4% Lidocaine Cream Recall 178 Bottles (2026)

Stability Data Does Not Support Expiry Date.

Kirkman MAXIMUM ZONE 2 4% Lidocaine Cream Recall for Expiry Stability Issue (2026)

Stability Data Does Not Support Expiry Date.

Nilotinib Capsules Recall Expands in 2026 Over Stability Issue (Cipla USA)

Cipla USA recalls 271 cartons of Nilotinib 150 mg capsules nationwide after stability tests show out-of-spec results. The issue affects description and appearance by visual inspection. Stop using and contact Cipla USA or a clinician for guidance.

K Kirkman FIVE-STAR VASOCAINE Spray Recall for Expiry-Date Stability Issue (2026)

Stability Data Does Not Support Expiry Date.

Nilotinib Capsules 200 mg Recall: 164 Cartons Nationwide in 2026

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Molded Products MPC-130 See Luer Cap Set Recalled for High-Risk Assembly Issue (2026)

Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.

Midodrine Hydrochloride Tablets Recall 8,892 Cartons Nationwide (2026)

Defective container; inadequately sealed blister packaging.

Medline Anterior Hip Pack Recall Affects 14,379 Kits With Olympus Biopsy Valves (2026)

Abiomed Impella Automated Controller Recall 62 Units in 2026

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Medline Recalls 14,379 Olympus Biopsy-Valve Kits in 2026