FDA medical device recalls

Merit Medical Systems is recalling certain BioFlo DuraMax Catheters because the sheath introducer may not split as designed. This defect could lead to complications during medical procedures, including bleeding, blood clots, or difficulty removing the catheter.

Merit Medical Systems is recalling certain DuraMax chronic hemodialysis catheters due to a design defect in the 16F dual-valved splittable sheath introducer. The sheath may not split properly during insertion, which could cause bleeding, blood clots, catheter malfunction, or loss of future vascular access.

Merit Medical Systems is recalling specific lots of its 16F dual-valved splittable sheath introducer because of a design defect that may prevent it from splitting properly during use. This could lead to serious complications including bleeding, blood clots, or damage to blood vessels.

Merit Medical Systems is recalling certain ProGuide Chronic Dialysis Catheters with a 16F dual-valved splittable sheath introducer due to a design defect. The sheath may not split as intended during insertion, which could cause serious complications including bleeding, blood clots, or damage to blood vessels.

Merit Medical Systems is recalling certain CentrosFLO hemodialysis catheters because the introducer sheath may not split properly during placement. This design defect could lead to bleeding, blockages, or difficulty placing the catheter correctly.

Erbe USA Inc is recalling specific lots of Flexible Cryoprobe devices used in surgery because the probes may rupture or burst when activated. This defect could affect patient safety during the procedure. No injuries have been reported to date.

Erbe USA Inc. is recalling certain Flexible Cryoprobe surgical devices (model OD 1.7mm, L1.15mm, REF: 20402-410) because the probes may rupture or burst when activated during surgery. This defect could cause injury to patients or surgical staff. No injuries have been reported so far.

Erbe USA has recalled certain flexible cryoprobes used in surgery because they may rupture or burst when activated. The defect could cause unexpected device failure during a procedure. No injuries have been reported, but the risk requires immediate action.

Datascope's Battery Charging Station (Model 0998-00-0802) for Cardiosave IABP batteries has a protruding screw in the left bay that can prevent certain batteries from inserting fully and charging properly. The right bay works normally. This affects 28 units distributed in select U.S. states and international locations.

Hologic's Aptima HPV Assay test kits (Master Lot 929785) may produce invalid results or false negatives, meaning they could fail to detect HPV infection. The affected kits were distributed to healthcare facilities in California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico, and Tennessee.

Diagnostica Stago's STA Liatest D-Di blood test kits are giving inaccurate measurements for D-dimer (a marker used to help rule out blood clots). The kits are showing higher-than-actual results across all test ranges. These kits are used in hospital and reference laboratories on specific analyzer machines.

ConvaTec has recalled certain EsteemBody Drainable Pouches (REF: 423657, 10-35mm) because they may leak due to a manufacturing issue. The affected pouches have lot number 5J03908. No injuries have been reported.

ConvaTec has recalled certain EsteemBody Drainable Pouches (model REF:423653, 10-35mm) because they may leak due to a manufacturing issue. The affected product has lot number 5K01728. No injuries have been reported.

ConvaTec's EsteemBody Drainable Pouch (model REF:423643, 10–45mm) may leak because of a manufacturing issue. The affected pouches have lot numbers 5K00011 or 5K00714 and have been distributed worldwide. No injuries have been reported.

Elekta has recalled certain Leksell Gamma Knife Perfexion and Icon radiosurgery systems because an adapter component may not be properly aligned or locked in place. This could affect the accuracy of radiation delivery during treatment. No injuries have been reported.

Some Stryker Cub Pediatric Cribs sold in the USA are missing two warning labels on the access doors. This affects 590 cribs with specific serial numbers. No injuries have been reported.

LeMaitre Vascular is recalling one unit of Artegraft Vascular Graft (Model AG740) distributed in Illinois due to a labeling mix-up on the outer packaging. The product box was labeled with an incorrect lot number, which could cause confusion during clinical use. No injuries have been reported.

The Welch Allyn Spot Vision Screener VS100 (software version 3.2.0.1) may display an unintended flickering screen due to a software issue. Flickering lights can trigger seizures in people who are photosensitive.

The external screws that secure the cover on the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment may loosen during use and detach. This affects all units with part number 210490 distributed across the United States and several other countries. No injuries have been reported.

GE Medical Systems' Centricity Universal Viewer software versions 5.0 SP6 through 5.0 SP7.1 has a cybersecurity weakness that may expose user login credentials on affected workstations. An unauthorized person could potentially use these exposed credentials to access the system, disrupt service, or alter medical images and data.

Certain versions of GE Centricity Universal Viewer software (versions 6.0 through 6.0 Sp10.4.1) contain a cybersecurity vulnerability that may expose user login credentials on affected workstations. An unauthorized person could potentially access the system and interfere with medical imaging data or system availability.

Certain versions of GE Centricity Universal Viewer software (versions 7.0 through 7.0 Sp2.0.1) contain a cybersecurity vulnerability that may expose user login credentials on workstations. An unauthorized person could potentially access the system and disrupt service or alter medical image data.

Abbott Diagnostics has recalled certain lots of the ID NOW Influenza A & B 2 test kit because they produce an unusually high number of invalid results compared to what the instructions say to expect. Invalid results mean the test does not give a clear positive or negative answer, requiring a retest.

Medline surgical drapes and gowns may fall apart (delaminate) when washed using the included instructions. If a delaminated drape is used during surgery, it could tear and allow bacteria through, increasing infection risk.

Medline surgical gowns may develop fabric separation (delamination) when laundered using the included instructions. If a separated gown is used during surgery, fluid or bacteria could pass through the compromised fabric, potentially increasing infection risk.

Medline and Cardinal Health have recalled specific lots of chest drainage kits used in cardiac surgery because the instructions needed to clarify that these devices are intended only for adult patients age 18 and older. The kits were distributed nationwide in California and internationally to Chile and Panama.

Altruan GmbH distributed Bisaf Strep A Self-Test kits without FDA clearance. This test is designed to detect group A streptococcal antigens in throat swabs, but has not been reviewed or approved by the FDA for safety and effectiveness. About 188 units were distributed nationwide.

Altruan GmbH distributed Clearest Strep-A Cassette Test kits that were not cleared or approved by the FDA before being sold. These tests are designed to detect group A streptococci (Strep A) in throat swab samples. About 188 units were distributed nationwide.

Wondfo Streptococcal A At-Home Self-Test kits were distributed in the US without FDA clearance. This means the test's accuracy and safety have not been verified by the FDA. If you have this test, results may not be reliable.

The Lutronic CLARITY II Laser System (Model 1110200210) may spark or pop during use, potentially causing burns to patients. The FDA has identified over 1,500 affected units based on serial number.