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Certain lots of the Quidel QuickVue Dipstick Strep A Test may return false positive results, meaning the test could indicate a strep infection when one is not actually present. This could lead to unnecessary antibiotic treatment. The recall affects specific lot numbers distributed across the US.

Moderate·FDA·May 20, 2026·Quidel

Hologic is recalling 2 mammography system product lines, covering about 19,140 units nationwide. The company received complaints that internal bolts in these systems can become loose, missing, or broken over time. No injuries have been reported.

Moderate·FDA·May 20, 20262 products

Stryker Corporation recalled a limited lot of FluidSmart Urology Tube Sets (REF LL0006) used with fluid management systems in surgical procedures. Some units in this lot did not meet manufacturing standards. No injuries have been reported.

Moderate·FDA·May 20, 2026

Dexcom is recalling three software products for the G7 and ONE+ continuous glucose monitoring apps on iOS and watchOS. A software defect can delay glucose readings and trend arrows while the app runs in the background, and old readings may then appear in sequence when the app is reopened. No injuries have been reported.

Moderate·FDA·May 20, 20263 products

Diowave 250W infrared laser systems used for temporary muscle and joint pain relief are operating at a maximum power output of 70W, which exceeds the FDA-cleared limit of 60W. A software update is required to correct the power output to the approved level.

Moderate·FDA·May 20, 2026·Technological Medical Advancements

A subset of Jolife LUCAS 2, LUCAS 3, and LUCAS 3.1 chest compression devices did not have complete service documentation on file. The service records lack paperwork that would verify these devices passed their required checks. This affects 153 devices across 20 U.S. states.

Moderate·FDA·May 20, 2026·Jolife

GE HealthCare found a potential security weakness in AW Server, a software application used with certain Revolution CT scanners through the Edison Health Link CT Smart Subscription. This recall covers 7 CT scanner products, with 146 units affected in total. No injuries have been reported.

Moderate·FDA·May 20, 20267 products

On-X Life Technologies released and distributed 10 mitral heart valves (Model ONXMC-25/33) before completing all required quality and performance testing. Because testing was incomplete, the company cannot confirm the valves meet all safety and performance specifications. The affected valves were distributed internationally to South Korea.

Moderate·FDA·May 20, 2026·On-X Life Technologies

Ascend Laboratories is recalling one lot of metoprolol succinate extended-release 25 mg tablets because they failed to meet dissolution specifications. This means the tablets may not break down and release the medication properly in the body. The affected lot was distributed nationwide.

Moderate·FDA·May 20, 2026

Endo USA is recalling certain batches of buprenorphine hydrochloride 0.3 mg/mL injection due to the presence of particulate matter identified as buprenorphine free base in the vials. The affected lots are 84132 (expiration 02/28/2027) and 87693 (expiration 03/31/2027). No injuries have been reported.

Moderate·FDA·May 20, 2026·Endo USA

Oasis Medical is recalling specific lots of Oasis Tears PF preservative-free eye drops because the FDA found concerns about sterility assurance during an inspection. No injuries have been reported, but the company is recalling the product out of caution.

Moderate·FDA·May 20, 2026·Oasis Medical

Pharmacal recalled one lot of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream (6oz tube, lot 1024088) because it was found to contain Staphylococcus aureus bacteria. The contaminated product could cause infections ranging from localized skin infections to serious conditions like sepsis, especially in people with weakened immune systems or compromised skin. No illnesses have been reported so far.

Moderate·FDA·May 8, 2026·Pharmacal

Teva Pharmaceuticals is recalling specific lots of Claravis (isotretinoin) 10 mg capsules because they contain higher-than-allowed levels of tretinoin, a related chemical impurity. The affected lots are 100067507 and 100067508, which expire on July 31, 2026. No injuries have been reported so far.

Moderate·FDA·Apr 29, 2026

Philips has identified three software issues in the Spectral CT on Rails Model 728334 that may affect scan operations. The gantry (rotating scanner) may not move to the correct position after pressing start; a required confirmation message may not appear; and a menu option may become unavailable during brain imaging setup. Three systems worldwide are affected.

Moderate·FDA·Apr 22, 2026

Medline distributed one lot of CENTURION Circumcision Kits (lot number 25KLA002) without completing the required sterilization process. This means the kits are not sterile and could pose an infection risk if used. The affected kits were distributed in South Carolina.

Moderate·FDA·Apr 22, 2026

The Gentuity HF-OCT Imaging System may display repeated image frames during a pullback procedure when used with certain catheters, which could affect the accuracy of length measurements. This issue affects specific software versions (21.11 to 23.3.13) paired with Vis-Rx and Vis-Rx Prime catheters. No injuries have been reported.

Moderate·FDA·Apr 22, 2026·Gentuity

The centrifuge bowl on certain Cellex Photopheresis System kits may be difficult to install properly onto its holder. If not installed correctly, the bowl can break during use, which could delay patient treatment and cause blood loss.

Moderate·FDA·Apr 22, 2026·Theranos

Clariance-SAS is recalling multiple lots of Elegance Anterior Cervical Plates (used in neck spine surgery) due to burrs found on some finished plates. The burrs are sharp edges that could cause injury during or after implantation. No injuries have been reported so far.

Moderate·FDA·Apr 22, 2026·Clariance

Integra LifeSciences is recalling five sizes of Cytal Wound Matrix and Cytal Burn Matrix products because an increased rate of endotoxin test results fell outside acceptable limits. The recall covers 879 units distributed across many US states. No injuries have been reported.

Moderate·FDA·Apr 22, 20265 products

3B Medical distributed 2 units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet the company's internal quality standards. The devices were distributed in New York. No injuries have been reported.

Moderate·FDA·Apr 22, 2026·3B Medical

Siemens has recalled certain ARTIS Pheno VE30A and VE40A imaging systems used in hospitals and medical facilities. During 3D imaging procedures, these systems may produce images with uneven brightness, potentially leading to less accurate reconstructions and unintended low-dose radiation exposure to patients.

Moderate·FDA·Apr 22, 2026

Wilson-Cook Medical is recalling Instinct Plus Endoscopic Clipping Devices (model G58010) due to increased complaints about potential device malfunction during use. The recall affects units manufactured between September 2, 2023 and April 20, 2025 and distributed worldwide. No injuries have been reported.

Moderate·FDA·Apr 22, 2026

The LinkBio CORE Workstation, part of the CORE Shoulder System, may show an incorrect Planning Date when you view cases in the Start Case menu. This could lead to confusion about case timing. Five units are affected across Alabama, Florida, and Kansas.

Moderate·FDA·Apr 22, 2026·Linkbio

Remel's Yeastone Broth (11ML, 10/BOX, model YY3462) may give wrong results when labs use it to test how fungi respond to antifungal medicines. If a lab doesn't catch the bad result during its own quality checks, doctors might delay treatment or switch to a different antifungal drug unnecessarily.

Moderate·FDA·Apr 22, 2026

Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.

Moderate·FDA·Apr 22, 2026

Avantor Performance Materials has recalled Magnesium Chloride, 6-Hydrate Crystal (500G bottles, Lot 23G3161005, expiration 9/21/2027) because the product does not meet strength specifications. This bulk pharmaceutical ingredient may be less potent than labeled.

Moderate·FDA·Apr 22, 2026·Avantor

Island Kinetics, Inc. (d.b.a. CoValence Laboratories) is recalling specific lots of Skin Script Blemish Spot Treatment because the product failed stability testing. This means the product may not maintain its intended strength or safety over time. No injuries have been reported.

Moderate·FDA·Apr 22, 2026·CoValence Laboratories

Major Pharmaceuticals is recalling memantine hydrochloride extended-release 7 mg capsules (lot N02425, expiring 05/31/2027) because the capsules may not dissolve properly in the body. This means the medication may not work as intended. The affected capsules were distributed nationwide.

Moderate·FDA·Apr 22, 2026

International Medication Systems Ltd. is recalling one lot of epinephrine injection due to concerns that the sterility of the product cannot be assured. The affected lot (EA038A5, expiring 08/2026) was distributed nationwide. No injuries have been reported.

Moderate·FDA·Apr 22, 2026·International Medication Systems

CoValence Laboratories is recalling three hydrocortisone 1% skin gels because they may contain less hydrocortisone than the label states. The recall covers Remedy Gel (distributed by glo Skin Beauty), and Skin Rehab Calming Skin Gel and Essential Calming Skin Gel (both distributed by A.C.E. Inc.). No injuries have been reported.

Moderate·FDA·Apr 22, 2026·CoValence Laboratories3 products