FDA medical device recalls

SeaSpine Orthopedics has recalled certain Polyaxial Head spinal implants (REF 41-3010) due to a manufacturing error that may cause the polyaxial head to detach from the screw during surgery after insertion. This could require additional surgical intervention. The recall affects 796 units distributed worldwide, including nationwide US distribution and locations in Chile and Australia.

Olympus has identified a potential fault in the HDMI and DisplayPort connectors on certain OEV321UH 4K UHD LCD Monitors. This fault can result in image loss or display abnormalities. The recall affects 10 units with specific serial numbers distributed in Ohio, California, New Jersey, Florida, and Japan.

The roller assembly on the Ferno-Washington Power F2 Powered Fastening System may wear unevenly and deform, causing the rail mechanism to jam. If this happens, the stretcher cannot move along the rail—either with the powered system or manually—potentially delaying patient transport to a hospital.

ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.

Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.

Boston Scientific identified that certain FARADRIVE Steerable Sheath devices may develop damage to the hemostatic valve if the dilator is not inserted correctly during preparation. Valve damage can allow air to enter the device, which may lead to air embolism—a serious condition where air bubbles reach the bloodstream and heart.

Boston Scientific identified that certain lots of the FARADRIVE Steerable Sheath (CLEAR) may have a hemostatic valve that can be damaged during device preparation if the dilator is not inserted correctly. Valve damage can allow air to enter, potentially causing an air embolism and patient harm.

Boston Scientific has identified that certain lots of the FARADRIVE steerable sheath may develop damage to the hemostatic valve during preparation if the dilator is not inserted correctly. This valve damage can allow air to enter the device, which may lead to air embolism (air in the bloodstream) and patient harm.

Boston Scientific identified that improper dilator insertion during device setup can damage the hemostatic valve in the FARADRIVE Steerable Sheath. Valve damage may allow air to enter the device, potentially causing air embolism and patient harm. The risk occurs in a subset of affected units when the dilator is not inserted straight through the center of the valve.

Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.

Boston Scientific distributed 11 FARASTAR PFA Generator devices with Instructions For Use that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed one FARASTAR Pulsed Field Ablation Generator with instructions that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed 18 FARASTAR Ablation Generator units in Europe with incomplete Instructions For Use (IFU). The labeling did not include information about the FARAPOINT PFA catheter, which is used with the device. This discrepancy could affect proper device setup and use.

Medline Industries is recalling specific surgical convenience kits used in joint replacement procedures because they contain a pain-reliever medication (Bupivacaine Hydrochloride in Dextrose) with quality problems. The medication was manufactured by Huons Co, Ltd. and distributed through B. Braun Medical. The quality issues were identified by the supplier and no injuries have been reported.

Medline Industries is recalling specific C-section convenience kits (SKU DYNJ910835 and DYNJ910835A) that contain an anesthetic medication with quality problems. The anesthetic, Bupivacaine Hydrochloride in Dextrose Injection, was recalled by its manufacturer due to quality issues.

Medline Industries is recalling specific Anterior Hip surgical kits (SKU DYNJ909640G) that contain a B. Braun convenience kit with Bupivacaine Hydrochloride in Dextrose Injection. The anesthetic component was manufactured by Huons Co, Ltd., which issued a voluntary recall due to quality concerns with the injectable drug.

Wilcox Industries has released a software enhancement designed to increase the safety of its BOSS Xe aiming devices. The company is notifying all customers who purchased these products that the update should be installed.

Tosoh Bioscience recalled certain lots of its ST AIA-Pack Testosterone test due to a quality control issue that can produce falsely high or falsely low testosterone measurements. Inaccurate results may lead to unnecessary follow-up testing or delayed diagnosis.

The Photera 600 3-D ultraviolet phototherapy device used to treat skin disorders has a calibration error in how it calculates UV output. A sensor setting was incorrectly applied, causing the device to deliver lower UV intensity than intended. This affects 212 units distributed nationwide.

The Photera 600 ultraviolet phototherapy device was found to have an error in how it calculates UV output. A sensor setting was incorrect, causing the device to deliver lower UV levels than intended. This affects 26 units with specific serial numbers distributed nationwide.

The Photera 400 ultraviolet phototherapy device uses a sensor to measure and control UV output for treating skin disorders. A calibration error caused the sensor to report incorrect UV levels, which means patients may have received different doses than intended.

Maquet (now Getinge) identified that 205 units of the Vasoview Hemopro 2 endoscopic vessel harvesting system from a single lot were exposed to an incorrect sterilization dose during gamma sterilization processing. This occurred at a STERIS facility in New Jersey in late March 2026. The affected devices may not be adequately sterilized.

3B Medical is recalling Rio II nasal pillows interfaces due to a packaging and labeling discrepancy affecting product size identification and device identifiers. The affected units have incorrect or mismatched labeling on certain lots, which could lead to patients receiving the wrong size for their CPAP or PAP therapy device.

Medtronic received two complaints of loose foreign material inside the Bio-Medicus Adult Cannula Kit used during heart-lung bypass surgery. Testing confirmed the material contained trace levels of blood. No injuries have been reported.

Medtronic received two complaints of loose foreign material inside the DLP One-Piece Pediatric Arterial Cannula (Product Number 77010), a tube used during heart-lung bypass surgery in children. Testing confirmed the material contained trace levels of blood. No injuries have been reported.

Medline kits containing Zimmer Biomet mixing bowls and spatulas have seal defects that could compromise sterility during knee replacement surgery. The issue may require surgeons to obtain replacement equipment during the procedure, but no patient injuries have been reported.

Medline surgical kits containing Zimmer Biomet mixing bowls and spatulas have a seal defect that could compromise sterility. This defect could require surgeons to find an alternative device during a procedure. No injuries have been reported.

Papablic Replacement Brush Heads (Model PAPA317AA) may break during use. The recall affects specific lot numbers: PS2509A01, PS2511A01, and PS2512A01. No injuries have been reported.

Papablic Replacement Brush Heads (Model Papablic18B) with specific lot numbers may break during use. The recall affects about 14,700 packs sold nationwide with lot numbers PS2509A01, PS2511A01, or PS2512A01 (date codes 2509, 2511, 2512).

Orthofix external fixation devices used in orthopedic and trauma surgery have been shipped with incorrect labels. Some M101 models were labeled as M103, M103 models as M101, and M122 models as M111. This labeling error could lead to selection of the wrong device size during surgical procedures.