Open, ClassifiedPosted Oct 6, 2025·Initiated Sep 9, 2025
NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I
Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Root cause: Software design
Recalling firm: NOXBOX LTDType: Apparatus, Nitric Oxide DeliveryDistribution: Domestic: TNRecall #Z-0028-2026
Open, ClassifiedPosted Oct 6, 2025·Initiated Sep 9, 2025
NOxBOXi Nitric Oxide Delivery System;
Model Numbers: NOXBOX-I
Reason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Root cause: Software design
Recalling firm: NOXBOX LTDType: Apparatus, Nitric Oxide DeliveryDistribution: Domestic: TN;Recall #Z-0029-2026
Open, ClassifiedPosted Oct 3, 2025·Initiated Aug 29, 2025
ClariTEE Miniaturized TEE probe. Model Number: CLT-010.
Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Reason: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Root cause: Process control
Recalling firm: ImaCor Inc.Type: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.Recall #Z-0038-2026
Open, ClassifiedPosted Oct 3, 2025·Initiated Aug 18, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Root cause: Unknown/Undetermined by firm
Recalling firm: CORNEAT VISION, LTD.Type: Prosthesis, Eyelid Spacer/Graft, PolymerDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.Recall #Z-0039-2026
Open, ClassifiedPosted Oct 3, 2025·Initiated Aug 18, 2025
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Root cause: Unknown/Undetermined by firm
Recalling firm: CORNEAT VISION, LTD.Type: Prosthesis, Eyelid Spacer/Graft, PolymerDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.Recall #Z-0040-2026
Open, ClassifiedPosted Oct 3, 2025·Initiated Aug 29, 2025
Optiflux High Flux E-beam Dialyzer
Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Reason: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Root cause: Device Design
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialyzer, Capillary, Hollow FiberDistribution: US Nationwide distribution.Recall #Z-0041-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0018-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0019-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0020-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0021-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0022-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0023-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0024-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 29, 2025
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159.
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
This model is not cleared for marketing in the US.
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause: Process control
Recalling firm: Northeast Scientific Inc.Type: Reprocessed Atherectomy CatheterDistribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.Recall #Z-0025-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Root cause: Process control
Recalling firm: Aesculap AGType: Motor, Drill, PneumaticDistribution: US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.Recall #Z-0026-2026 Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Root cause: Process control
Recalling firm: Aesculap AGType: Motor, Drill, PneumaticDistribution: US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.Recall #Z-0027-2026 Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 13, 2025
Change Healthcare Radiology Solutions software version 14.2.2
Reason: Due to software issue, radiology reports may not be fully displayed when viewing.
Root cause: Software Design Change
Recalling firm: CHANGE HEALTHCARE CANADA COMPANYType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.Recall #Z-0030-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated Aug 4, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Reason: On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Root cause: Software Design Change
Recalling firm: Beckman Coulter Inc.Type: Radioimmunoassay, CortisolDistribution: Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of KoreaRecall #Z-0032-2026
Open, ClassifiedPosted Oct 2, 2025·Initiated May 7, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Reason: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Root cause: Process design
Recalling firm: Medtronic MiniMed, Inc.Type: Sensor, Glucose, InvasiveDistribution: US: No distribution
OUS: Austria, Belgium, Italy, Spain, Switzerland, United KingdomRecall #Z-0033-2026 Open, ClassifiedPosted Oct 2, 2025·Initiated Sep 2, 2025
Artegraft Collagen Vascular Grafts
Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Reason: The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Root cause: Nonconforming Material/Component
Recalling firm: LeMaitre Vascular, Inc.Type: Tissue Graft Of 6mm And GreaterDistribution: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.Recall #Z-0034-2026