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When using two or four amplifiers together in certain configurations, the SD LTM 64 PLUS may display a 1-second timing delay between channel blocks. This delay could cause doctors to misinterpret EEG test results. The issue affects devices running specific firmware versions.

Moderate·FDA·Jun 17, 2026·Micromed

Avanos Medical is recalling 20 PEG feeding tube kits sold under the CORFLO and MIC Safety names. The kits were made with lidocaine hydrochloride injection that is itself subject to a supplier recall for quality issues. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Avanos Medical20 products

HF Acquisition Co LLC is recalling the SporeTraq Mail-In Spore Testing Service (52 tests) because some test strips were not incubated for the correct length of time. The test strips are used by healthcare facilities to verify that their sterilization equipment is working properly. Incorrect incubation times can produce unreliable test results.

Moderate·FDA·Jun 17, 2026·HF Acquisition2 products

InspireMD is recalling six sizes of its CGuard Prime Carotid Stent System, covering 1,377 units in total. The stent delivery system may run into complications during deployment, which can cause high resistance or prevent the stent from being deployed. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·InspireMD6 products

D.O.R.C. has recalled certain TDC VELOCE 23G Two Dimensional Cutters used in ophthalmic surgery because the outer knife can become loose during use. An increased number of complaints about this issue prompted the recall. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·D.O.R.C3 products

Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.

Moderate·FDA·Jun 17, 2026

Some Berlin Heart EXCOR Pediatric Ventricular Assist Device blood pumps have mismatched expiration dates between the inner and outer package labels. The inner package shows an incorrect expiration date, which could cause confusion and delay surgical procedures if the device is not used on time.

Moderate·FDA·Jun 17, 2026·Berlin Heart

Certain lots of Mozarc Medical's Mahurkar Elite PASS Trays are missing the Tegaderm CHG antimicrobial dressing that is supposed to be included in the kit. These trays are used in hospitals and clinical settings for acute hemodialysis, aphaeresis, and infusion procedures. The missing dressing may affect the product's intended sterile barrier protection.

Moderate·FDA·Jun 17, 2026·Mozarc Medical

GE HealthCare found a possible problem with an electrical cable in certain Allia IGS X-ray systems that use Gaia generators. The issue could expose service personnel to electrical shock while working inside the C-FRT cabinet with power on. This recall includes 5 product lines, with 173 affected units in total.

Moderate·FDA·Jun 17, 20265 products

ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.

Moderate·FDA·Jun 17, 20263 products

A manufacturing defect in the Fresh Roast Systems ColorTrack model BENCH R-100 could, under rare misuse conditions, expose users to infrared laser light levels higher than the product's safety rating. No injuries have been reported. The defect affects a small number of units.

Moderate·FDA·Jun 17, 2026·Fresh Roast Systems

Sensory Supplement LLC is recalling Neuro Nourish, a 6-in-1 dietary supplement, due to premature lipid oxidation during storage. Affected product may have an off odor and bitter taste, though no injuries have been reported.

Moderate·FDA·Jun 17, 2026·Neuro Nourish2 products

Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.

Moderate·FDA·Jun 17, 2026

Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, 115 mg (lot 25141635, expires 4/30/2028) because testing found the tablets did not dissolve properly as required. This affects 360 bottles distributed nationwide. No injuries have been reported.

Moderate·FDA·Jun 17, 2026

Golden State Medical Supply is recalling specific lots of niacin extended-release tablets (1,000 mg) because they failed to dissolve properly during stability testing. The tablets did not meet dissolution specifications at the 24-hour mark, which means they may not release the medication as intended in the body.

Moderate·FDA·Jun 17, 2026

Zep Inc. is recalling Alcohol Sanitizer Spray (Ethanol 70%, 55-gallon drums) due to microbial contamination. The affected batch (E2612116, expiration April 2029) was distributed nationwide. A total of 5 drums are involved.

Moderate·FDA·Jun 17, 2026·Zep

Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.

Moderate·FDA·Jun 17, 2026

Breckenridge is recalling two sizes of duloxetine delayed-release capsules, 30 mg and 60 mg, made by Towa Pharmaceutical Europe in Spain. The recall covers about 374,400 bottles distributed nationwide. The capsules contain an impurity called N-nitroso-duloxetine at a level above the FDA's recommended interim limit. No injuries have been reported.

Moderate·FDA·Jun 17, 20262 products

Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.

Moderate·FDA·Jun 17, 2026

Beekeeper's Naturals Saline Nasal Spray was manufactured without proper sterilization, allowing microbial contamination. The affected product is Lot #5950 with an expiration date of 02/2028. No injuries have been reported so far.

Moderate·FDA·Jun 17, 2026·Beekeeper's Naturals

Some Medline EYE TRAY-LF convenience kits (SKU DYNJ21627P) contain syringes labeled as tuberculin syringes on the box, but the actual syringes inside are insulin syringes. Using the wrong syringe type could lead to incorrect dosing.

Moderate·FDA·Jun 3, 2026

Philips is recalling Azurion and Allura imaging systems because the hard drives in their PCs may slow down as they age, especially after six years of use. Depending on the system, this can cause loss of imaging function, and in Allura systems it may also cause loss of motorized movement or data loss. A system restart may temporarily restore function. No injuries have been reported, and the recall covers 2 product lines with about 3,069 affected units.

Moderate·FDA·Jun 3, 20262 products

GE HealthCare has identified a situation where the ApexPro CARESCAPE Telemetry Server (versions 5.0 and 6.0) can lose ECG and SpO2 monitoring data if the system loses network connection to the central monitoring station. This affects 14 units used in hospitals and clinical settings.

Moderate·FDA·Jun 3, 20266 products

A limited number of Medtronic 1x4 Pocket Adaptor Kits (Models 64001 and 64002) used in deep brain stimulation devices are labeled with incorrect Use-By-Dates. The mislabeled kits may no longer be safe or effective for their intended use.

Moderate·FDA·Jun 3, 20262 products

Devicor Medical Products is recalling HydroMARK Breast Biopsy Site Marker Model 4010-02-15-T3 due to incorrect labeling on individual packages inside boxes. Some boxes labeled as T3 markers may contain packages labeled as T4 markers, which could lead to use of the wrong marker type during a breast biopsy procedure.

Moderate·FDA·Jun 3, 2026·Devicor

Halyard Purezero Ultraviolet Nitrile Exam Gloves in sizes XS through XL failed to meet chemical permeation performance standards, meaning they may not provide adequate protection against certain chemicals. This affects approximately 452,500 units distributed nationwide.

Moderate·FDA·Jun 3, 2026·Halyard

AVEVA nicotine patches (14 mg) distributed by Rugby Laboratories have elevated levels of chemical impurities that exceed safety standards for shelf life. The issue was discovered during stability testing of specific lots. No injuries have been reported.

Moderate·FDA·Jun 3, 2026·AVEVA

Philips is recalling X-ray tube cooling units, type CU3101, that were made between February 2016 and May 2020. The deaeration hose may degrade and leak oil, which can reduce cooling. When oil flow drops too low, the system switches to low-dose fluoroscopy and shows a tube cooler message that restarting does not clear. The recall covers 3 product lines with about 5,000 affected units, and no injuries have been reported.

Moderate·FDA·May 27, 20263 products

C.R. Bard has recalled certain Silastic Brand Foley Catheters (5cc and 30cc models) due to staining on the catheter surface. The affected catheters were distributed across the U.S. and Canada.

Moderate·FDA·May 27, 2026

Certain Philips Azurion fluoroscopy systems may experience mechanical wear in the Float Tabletop control, which could impair the longitudinal and transverse (side-to-side and front-to-back) movement of the examination table. This wear could affect the system's ability to position patients correctly during imaging procedures.

Moderate·FDA·May 27, 2026