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Olympus is recalling four evacuator products, including Toomey and Ellik models, because some sterilization instructions may not reliably make the devices fully sterile. The recall covers about 8,250 units distributed in the US and internationally.

Moderate·FDA·Jul 22, 20264 products

Argon Medical Devices is recalling six procedure trays and kits, including the Transvenous Pacing Electrode Tray, One-Piece Introducer Tray, General Biopsy Tray, T-Lok Bone Marrow Tray, Arterial Line Kit, and Bone Marrow Tray. Some kits contain lidocaine ampules that are already subject to another recall, and the kits did not meet sterility release criteria. No injuries have been reported.

Serious·FDA·Jul 22, 2026·Argon Medical Devices6 products

Abiomed is recalling 13 Impella heart pump sets and introducer kits because the introducer sheath may leak from under the sheath cap and along the hub score lines. The problem affects 14Fr and 23Fr introducers, which come in every pump set, and users cannot see it visually. No injuries have been reported.

Serious·FDA·Jul 22, 202613 products

Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.

Serious·FDA·Jul 22, 2026·Oscor3 products

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.

Moderate·FDA·Jul 22, 2026

Chiesi USA is recalling specific lots of CLEVIPREX (clevidipine) injectable emulsion because the manufacturer cannot guarantee the vials are sterile. This affects vials distributed nationwide with lot numbers 1239521 and 1237454, expiring in October 2027. No injuries have been reported.

Moderate·FDA·Jul 22, 2026

Bell Pharmaceuticals is recalling 11 carbamide peroxide 6.5% ear drop products, all 0.5 fl oz (15 mL), sold under store and pharmacy brands. Testing found the drops contain far less active ingredient than the label states, and their acidity is also off. No injuries have been reported.

Moderate·FDA·Jul 22, 2026·Bell Pharmaceuticals11 products

Padagis Nystatin Cream USP (100,000 units, 15 g tube, lot #205060, expiring 09/30/2027) has been recalled because stability testing found the active ingredient fell below the required strength specification. The cream may not work as effectively as intended to treat fungal infections.

Moderate·FDA·Jul 22, 2026·Padagis

Four lots of Unique Pharmaceutical Cetirizine Hydrochloride 5 mg tablets were found to be cross-contaminated with ranitidine. The contamination was discovered when pharmacy staff noticed red discoloration on some tablets. People with sensitivity to ranitidine could experience serious allergic reactions.

Serious·FDA·Jul 18, 2026

Trafa Pharmaceuticals Inc. is recalling its organic moringa leaf powder (15 kg bags, batch #TRF-2025050801, manufactured May 8, 2025) due to potential Salmonella contamination. The affected product was distributed in New York.

Serious·FDA·Jul 15, 2026

Zimmer Biomet is recalling two A.T.S 4000 TS tourniquet system hoses because the sealing area of the sterile pouch may be breached. If used, the hose may cause a moderate, localized infection. If found before use, surgery may be briefly extended while another device is located.

Moderate·FDA·Jul 8, 20262 products

W L Gore & Associates has recalled specific batches of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation during use. This is a surgical implant used to repair certain aortic conditions. The separation could potentially affect the device's ability to function as intended.

Moderate·FDA·Jul 8, 2026·Gore

Masimo is recalling two Radius VSM products: an ECG pre-connected electrode set and disposable blood pressure cuffs, covering 1,800 units in total. The ECG feature may incorrectly flag abnormally slow or fast heart rates in patients with normal rhythms, which could distract clinicians from true alarms and delay treatment. The blood pressure cuffs may have rough edges that can cause skin irritation or redness. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Masimo Corporation2 products

Laborie Medical Technologies' Solar GI System water perfusion devices may accumulate moisture inside tubing, filters, and pressure sensors during extended clinical use. This moisture buildup can affect how the system measures airflow and pressure, potentially impacting test results.

Moderate·FDA·Jul 8, 2026·Laborie Medical Technologies Corp

Bard Access Systems is recalling 14 products, including PICC, midline, and dialysis catheters and biopsy trays. The recall stems from lidocaine ampoules that were made under deficient manufacturing practices, and the supplier is recalling them. No injuries have been reported.

Moderate·FDA·Jul 8, 202614 products

BD Switzerland inadvertently shipped 50 engineering sample units of the Medline 111 Gravity Set with 3 Needle Free Y-Sites into the U.S. market. These units were labeled "Not for Human Use" and were not intended for patient care. No injuries have been reported.

Moderate·FDA·Jul 8, 2026

The Shiley Disposable Decannulation Plug (DDCP), a red connector used on tracheostomy tubes to block airflow, carries labeling that incorrectly indicates it does not contain DEHP (a chemical compound). The product actually contains 30–35% DEHP. Users relying on the label may not be aware of DEHP exposure during use.

Moderate·FDA·Jul 8, 2026

Certain Zeiss Intrabeam Spherical Applicator 1.5 cm units used in intraoperative radiation therapy did not meet manufacturing specifications. A total of 13 units were affected across the United States, Puerto Rico, and several other countries. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Carl Zeiss Meditec

Siemens has identified a potential issue with the Display ceiling suspension (DCS Fix XL) component on ARTIS icono ceiling systems. Over time, screws that secure the monitor to the suspension may gradually loosen, which could affect the stability of the mounted display.

Moderate·FDA·Jul 8, 2026

RayCare 2024A SP1 oncology information system has a software issue where beam set delivery notes can lose data if modified at the same time or updated during an active treatment session. Users may not be notified when these changes occur, potentially affecting treatment records.

Moderate·FDA·Jul 8, 2026·Raysearch Laboratories2 products

Some Medela ENFit ExSet enteral extension sets contain incorrect connectors that may not attach properly to ENFit connections. This incompatibility could cause a slight delay in delivering nutrition or medication through the feeding tube.

Moderate·FDA·Jul 8, 2026·Medela Inc

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife treatment system. This triggers a safety interlock that blocks motion from the operator console. However, if staff enter the treatment room and use the in-room control pendant to move the system, the collimator can release and fall from its housing, creating a potential impact hazard.

Moderate·FDA·Jul 8, 2026·Accuray Incorporated

Siemens is recalling three models of its ARTIS icono imaging systems, 234 units in total, because the detector lift may stop moving after it is adjusted to its highest or lowest height limit. No injuries have been reported.

Moderate·FDA·Jul 8, 20263 products

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife system. If operators bypass the safety interlock by using the in-room control pendant, the collimator can release and fall from the machine housing. This affects 48 Cyberknife units worldwide running software version 11X or earlier.

Moderate·FDA·Jul 8, 2026·Accuray Incorporated

Pilling Wecksorb Neurosponges—sterile cotton sponges used during brain and spine surgery—may contain higher-than-safe levels of endotoxins (bacterial toxins). The affected sponges were manufactured between 2021 and 2024. No injuries have been reported, but elevated endotoxins could trigger an inflammatory response during surgery.

Moderate·FDA·Jul 8, 2026·TELEFLEX LLC

The Adapter for Head Positioning (Model 1739994) used with Baxter operating tables may become loose during patient positioning and move unintentionally. This affects 13 units distributed worldwide, primarily in Minnesota, Maryland, Pennsylvania, Canada, and numerous other countries.

Moderate·FDA·Jul 8, 2026

Boston Scientific is recalling 12 sizes of its CRE and CRE Pro Wireguided balloon catheters because the pouches they are packaged in may not keep the devices sterile. The recall covers 81,543 units per product and was distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Jul 8, 202612 products

The IntelliCuff portable cuff pressure controller may display a "Cuff System Leakage" error and cause the motor to pump continuously instead of maintaining the pressure set by the user. This can prevent the device from working as intended.

Moderate·FDA·Jul 8, 2026·Hamilton Medical AG

Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.

Serious·FDA·Jul 8, 2026·Medtronic Heart Valves Division

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

FDA·Jul 8, 2026