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Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.

Moderate·FDA·Jun 17, 2026

Boston Scientific is recalling the Model SC-4318 Clik X Anchor (Lot #35107836) because sterile anchors may lack proper sterility assurance. Approximately 43 units were distributed across six U.S. states.

Moderate·FDA·Jun 17, 2026

Boston Scientific is recalling two lines of reusable electrodes, CSK and TCN, because they may not meet expected performance levels. The recall covers 2 products with about 81,000 units total, distributed across the US and several other countries. No injuries have been reported.

Moderate·FDA·Jun 17, 20262 products

Fresenius Medical Care's Bicarby Dialysate (Model RFP-400-G) has incorrect barcode labeling on some units. While the case label and printed information are correct, scanning the GTIN barcode alone could lead to identification errors. This could result in use of a dialysate with a potassium concentration different from what was prescribed.

Moderate·FDA·Jun 17, 2026

Some units of Inter-Med's Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit (catalog 504600-28) contain the package insert for Ferric Sulfate Gel instead. The wrong insert gives incorrect first aid instructions—specifically, it tells users to induce vomiting if the gel is swallowed, when the correct instructions say not to induce vomiting.

Moderate·FDA·Jun 17, 2026·Inter-Med

DT MedTech discovered that some Hintermann Series Talar Implant units labeled as left implants actually contained right implants inside the packaging. This mix-up was found through customer complaints. A total of 67 units across five US states and two countries are affected.

Moderate·FDA·Jun 17, 2026·DT MedTech

Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.

Moderate·FDA·Jun 17, 2026

The EXENT Analyser, an automated blood-test device, has a software issue where certain test plates were marked as passed without performing required quality checks. This could allow inaccurate M-protein measurements—either missed detections or wrong concentration values—to be reported to clinicians.

Moderate·FDA·Jun 17, 2026·The Binding Site

Medartis has recalled certain APTUS 5.0 headed cannulated compression screws (CCS) used in bone fixation surgery because the central hole in the screw is not properly centered. This affects 13 units across five states. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Medartis

Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98-16mm zirconium oxide discs used in dental crowns and bridges. Some discs may have a reduced or missing dentin layer, which can weaken them and cause fractures when patients chew or bite.

Moderate·FDA·Jun 17, 2026·Sagemax

In2bones USA has recalled NeoSpan SuperElastic Compression Staples used in hand and foot surgery because the required Magnetic Resonance Imaging (MRI) safety symbol is missing from the product packaging, inner trays, and patient labels. This labeling omission could prevent patients and healthcare providers from knowing whether the implant is safe to use during an MRI scan.

Moderate·FDA·Jun 17, 2026·In2bones

One Philips DigitalDiagnost C90 Flex/Value/Chest/ER X-ray system was shipped without the required Seismic kit for its Wall Stand VS2. The kit is designed to keep the stand stable and prevent damage during earthquakes or seismic events.

Moderate·FDA·Jun 17, 2026

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

Total Nutrition Inc is recalling TNVitamins and Doctor's Pride brand moringa capsule supplements because they may be contaminated with Salmonella. The recall affects 13,000 bottles sold nationwide across multiple lot numbers.

Serious·FDA·Jun 17, 2026

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

Gas-X Extra Strength softgels were contaminated with a diluted propylene glycol-based coolant during packaging due to a machine leak. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

Serious·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