FDA medical device recalls

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.

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.

Boston Scientific has recalled certain reusable TCN Electrodes used in neuromodulation devices because they may not perform as expected. The affected electrodes come in multiple sizes and configurations, with about 49,251 units distributed worldwide.

Boston Scientific has recalled certain CSK Electrode models used in neuromodulation procedures because they may not perform reliably as intended. The affected electrodes come in multiple configurations and lengths. No injuries have been reported to date.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Avanos Medical included lidocaine hydrochloride injections with quality issues in their MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) kits. The lidocaine was subject to a supplier recall for quality defects. About 1,205 kits across the US were affected.

Avanos Medical included lidocaine hydrochloride injections with quality issues in their MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) kits. The lidocaine was subject to a supplier recall for quality defects. About 6,000 kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injections with quality issues in sterile PEG (feeding tube) kits. The lidocaine was subject to a supplier recall for manufacturing defects. About 218 kits with specific lot numbers were affected nationwide.

Avanos Medical included lidocaine hydrochloride injections with quality defects in 234 sterile PEG kits. The injections were already the subject of a supplier recall. The kits affected are model 8170-24 in specific lot numbers distributed nationwide.

Avanos Medical included lidocaine hydrochloride injections with quality issues in certain sterile PEG (feeding tube) kits. The lidocaine was subject to a supplier recall for manufacturing defects. About 1,615 kits with specific lot numbers were affected nationwide.

Avanos Medical included lidocaine hydrochloride injection from a recalled supplier in sterile feeding tube kits. The supplier had recalled the lidocaine due to quality issues. Approximately 53 kits with lot number 30370718 were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injections with quality issues in their MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) kits. The lidocaine was subject to a supplier recall for quality defects. Approximately 1,006 kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injection from a supplier recall into sterile PEG (feeding tube) kits due to quality issues with the lidocaine. The affected kits are the MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr, with specific lot numbers ranging from 30371313 to 80403340.

Avanos Medical included lidocaine hydrochloride injections with quality issues in sterile PEG (feeding tube) kits. The lidocaine was subject to a supplier recall due to manufacturing problems. About 208 kits with specific lot numbers were affected.

Avanos Medical included lidocaine hydrochloride injections with quality issues in certain MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) feeding tube kits. The lidocaine was subject to a supplier recall due to manufacturing or quality problems. About 132 kits with specific lot numbers were affected.

Avanos Medical's MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) Kit 20 Fr includes lidocaine hydrochloride injection from a supplier that issued a recall due to quality problems. The affected kits were distributed nationwide; no injuries have been reported so far.

Avanos Medical included lidocaine hydrochloride injection with quality defects in 22 sterile feeding tube kits. The lidocaine was subject to a supplier recall for quality issues. The affected kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injection with quality issues in CORFLO Safety PEG feeding tube kits. The lidocaine was subject to a supplier recall and should not have been distributed in these sterile kits. The affected kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injection from a recalled supplier into 43 CORFLO Safety PEG Kits. The lidocaine had quality issues that could affect the sterility or safety of the kit. The affected kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injections with quality problems into 72 sterile CORFLO Safety PEG Kits. The lidocaine was subject to a supplier recall for manufacturing defects. The affected kits were distributed nationwide.

Avanos Medical included lidocaine hydrochloride injection from a supplier recall into 49 sterile CORFLO Safety PEG kits. The lidocaine was recalled by its supplier due to quality issues. Affected lot numbers are 30365230, 30367013, and 30373825.