Recalls and safety alerts from the FDA, newest first.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. — AVID Medical, Inc. · Class II · Ongoing · 112 kits
Due to manufacturing issues, reperfusion catheters may fractures — Penumbra, Inc. · Class II · Ongoing · N/A
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change. — Alphatec Spine, Inc. · Class II · Ongoing · 3
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hype… — Medtronic MiniMed, Inc. · Class II · Ongoing · 3,465
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. — Boston Scientific Corporation · Class II · Ongoing · 18 units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. — Medline Industries, LP · Class I · Ongoing · 318 kits
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. — ICU Medical Inc. · Class II · Ongoing · 39,750 units
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. — Karl Storz Endoscopy · Class II · Ongoing · 45
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. — Boston Scientific Corporation · Class II · Ongoing · 1 units
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of… — Ferno-Washington Inc · Class II · Ongoing · 278
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. — Medline Industries, LP · Class II · Ongoing · 398 kits
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. — Medline Industries, LP · Class II · Ongoing · 1601 units
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process. — Medtronic Neurosurgery · Class II · Ongoing · 167
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. — Micro Therapeutics, Inc. · Class II · Ongoing · 6 units
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. — Boston Scientific Corporation · Class II · Ongoing · 11 units
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. — Paragon 28, Inc. · Class II · Ongoing · 514 units
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose In… — Medline Industries, LP · Class I · Ongoing · 60 kits
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change. — Wilcox Industries Corp. · Class II · Ongoing · N/A
Incorrect concentration of Betadine solution contained within certain AVID convenience kits. — AVID Medical, Inc. · Class II · Ongoing · 260 kits
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected. — KENT IMAGING, INC. · Class II · Ongoing · 77