Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 23, 2026
Gentuity HF-OCT Imaging System Model G10-01;
Software version 23.2.13;
Reason: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Root cause: Device Design
Recalling firm: Gentuity, LLCType: Catheter, Intravascular, DiagnosticDistribution: Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX;
International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;Recall #Z-1823-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 16, 2026
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Reason: On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the state of South Carolina.Recall #Z-1824-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 7, 2026
Philips Spectral CT on Rails. Model Number: 728334.
Reason: Philips has identified three software issues:
1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go.
2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear.
3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.Recall #Z-1825-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model Number: SL-2010M2096A.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1798-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1799-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1800-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1801-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1802-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1803-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Feb 4, 2026
React Health PHOENIX 5L Oxygen Concentrator
Reason: Devices which did not meet internal quality specifications were inadvertently distributed.
Root cause: Storage
Recalling firm: 3B Medical, Inc.Type: Generator, Oxygen, PortableDistribution: US Nationwide distribution in the state of NY.Recall #Z-1815-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Reason: Increased rate of out-of-specification endotoxin results.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Wound Dressing With Animal-Derived Material(S)Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.Recall #Z-1816-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Reason: Increased rate of out-of-specification endotoxin results.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Wound Dressing With Animal-Derived Material(S)Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.Recall #Z-1817-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Reason: Increased rate of out-of-specification endotoxin results.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Wound Dressing With Animal-Derived Material(S)Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.Recall #Z-1818-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Reason: Increased rate of out-of-specification endotoxin results.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Wound Dressing With Animal-Derived Material(S)Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.Recall #Z-1819-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Reason: Increased rate of out-of-specification endotoxin results.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Wound Dressing With Animal-Derived Material(S)Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.Recall #Z-1820-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Feb 20, 2026
Brand Name: Elegance Anterior Cervical Plate
Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE
Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information"
Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a
variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation,
read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Reason: Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Root cause: Process change control
Recalling firm: Clariance-SASType: Appliance, Fixation, Spinal Intervertebral BodyDistribution: U.S. Nationwide distribution in the states of CA, IL, NY and TX.Recall #Z-1821-2026
Open, ClassifiedPosted Apr 13, 2026·Initiated Mar 3, 2026
Instinct Plus Endoscopic Clipping Device
REF: G58010
Rx Only, Sterile EO
Reason: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Root cause: Process control
Recalling firm: Wilson-Cook Medical Inc.Type: Hemostatic Metal Clip For The Gi TractDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, Brunei, Darussalam, Brazil, Canada, CANARY ISLANDS, Chile, China, Colombia, Costa Rica, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, Egypt, FINLAND, FRANCE, GERMANY, GREECE, Guatemala, Hong Kong, HUNGARY, Indonesia, India, IRELAND, ISRAEL, ITALIA, KUWAIT, LEBANON, LUXEMBOURG, MALTA, MAYOTTE, Mexico, Macao, MOROCCO, Malaysia, NEDERLAND, NORWAY, New Zealand, OMAN, PAKISTAN, Peru, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAUDI ARABIA, SLOVENIA, El Salvador, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Thailand, TURKEY, Taiwan, United Arab Emirates, United Kingdom.Recall #Z-1812-2026
Open, ClassifiedPosted Apr 10, 2026·Initiated Mar 12, 2026
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Reason: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
Root cause: Process design
Recalling firm: Insulet CorporationType: Alternate Controller Enabled Insulin Infusion PumpDistribution: Nationwide distribution.
Open, ClassifiedPosted Apr 10, 2026·Initiated Mar 19, 2026
Philips AneurysmFlow. Model Number: 001015.
AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
Reason: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Root cause: Labeling design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: System, Image Processing, RadiologicalDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bnis insted Us Instas instes, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait, Latvia, Macao, Maldives, Mongolia, Morocco, New Zealand, Nicaragua, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Switzerland, TURKEY, Ukraine, Utd.Arab.Emir., Uzbekistan, Vietnam.Recall #Z-1805-2026
Open, ClassifiedPosted Apr 10, 2026·Initiated Mar 24, 2026
Yeastone Broth, 11ML, 10/BOX
YY3462
Reason: Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Susceptibility Test Plate, AntifungalDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.Recall #Z-1806-2026