FDA medical device recalls

Avanos Medical included lidocaine hydrochloride injection in sterile kits. The lidocaine was subject to a supplier recall due to quality issues. The affected kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injection in CORFLO Safety PEG Kits that was subject to a supplier recall due to quality issues. The affected kits were distributed nationwide. No injuries have been reported.

Avanos Medical included lidocaine hydrochloride injection with quality issues into CORFLO Safety PEG Kit sterile sets. The lidocaine was subject to a supplier recall for manufacturing defects. Sixty-one kits with six lot numbers were affected.

Avanos Medical included lidocaine hydrochloride injections with quality issues in 231 CORFLO Safety PEG Kits (model 30-4320). The lidocaine itself was recalled by its supplier due to manufacturing problems. The affected kits were distributed nationwide.

SporeTraq Mail-In Spore Testing Service kits were processed with incorrect incubation times, which may affect the accuracy of sterilizer efficacy test results. The kits are used by healthcare facilities to verify that their sterilization equipment is working properly.

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.

The CGuard Prime Carotid Stent System (model CND1040, 10mm×40mm) may encounter complications during deployment, including high resistance or inability to deploy the stent properly. This affects 211 units manufactured between February 3 and February 23, 2026, distributed across the United States.

The CGuard Prime Carotid Stent System (model CND1030, 10mm x 30mm) may be difficult or impossible to deploy during surgery due to complications in the delivery system. This affects 114 units manufactured between February 3 and February 23, 2026. No injuries have been reported.

The CGuard Prime Carotid Stent System (model CND0940, 9mm × 40mm, 135cm length) may experience difficulty during placement in the artery. The delivery system could encounter high resistance or fail to deploy the stent properly.

The CGuard Prime Carotid Stent System (model CND0930, 135cm) may experience complications during deployment that could result in high resistance or inability to place the stent. This affects 147 units manufactured between February 3, 2025 and February 23, 2026, distributed nationwide.

The CGuard Prime Carotid Stent System (model CND0840, 8mm×40mm) may experience high resistance or fail to deploy properly during the placement procedure. This affects 424 units manufactured between early February 2025 and February 2026.

InspireMD's CGuard Prime Carotid Stent System (model CND0830, 8mm×30mm) may experience complications during deployment that could make it difficult or impossible to place the stent. About 190 units were distributed nationwide between February 2025 and February 2026. No injuries have been reported so far.

The outer knife on certain D.O.R.C. TDC VELOCE 27G surgical cutters may become loose during use. This surgical device is used in ophthalmic (eye) procedures, and a loose knife could affect device performance.

The outer knife on D.O.R.C. TDC VELOCE 25G surgical cutters can become loose during use. The company received an increased number of complaints about this issue across multiple lot numbers and article numbers distributed worldwide.

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.

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.

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.

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.

GE HealthCare identified a potential electrical cable issue on certain Allia Moveo angiographic X-ray systems equipped with Gaia generators. Service personnel who work inside the equipment cabinet while power is on could be exposed to electrical shock during installation, maintenance, or troubleshooting.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while power is on could be exposed to electrical shock.

GE HealthCare identified a faulty electrical cable on certain Allia IGS 7 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel working inside the C-FRT cabinet while the system is powered on could receive an electrical shock during installation, maintenance, or troubleshooting.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 5 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on face a risk of electrical shock.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while the system is powered on could be at risk of electrical shock.

The Plum Duo Precision IV Pump may fail to display a soft limit alert under certain conditions, meaning clinicians won't be notified before the pump starts delivering medication that exceeds the set safety limit. This could result in patients receiving too much or too little medication.

The Plum Duo Infusion Pump may fail to display alerts when medication delivery limits are exceeded. Without these warnings, clinicians may not know before the pump starts delivering the wrong amount of medication to a patient.

The Plum Solo Precision IV Pump may fail to display a soft limit alert under certain conditions, preventing clinicians from being notified of dosage limit violations before the pump starts delivery. This could result in incorrect medication doses being administered.

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.

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.

Hard drives in Philips Allura X-ray imaging systems may degrade after six years of use, potentially causing loss of imaging capability, motorized movement, or data. Some systems may temporarily restore function after a restart.

Hard drives in Philips Azurion imaging systems may degrade after six years of use, potentially causing loss of imaging capability. In some cases, the system may need to be restarted to restore function temporarily. Philips has identified this issue in multiple Azurion models used in medical facilities.