Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney Adhesive Hydrogel Sheet Dressing
Model/Catalog Number: 31720, 31740
Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with
Leptospermum Honey is a moist wound dressing made of
Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2508-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney Hydrogel
Model/Catalog Number: 31620, 31640
Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2509-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney Hydrogel Adhesive Sheet
Model/Catalog Number: 31722, 31744
Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2510-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: MediHoney
Product Name: MediHoney HCS Surgical Adhesive Sheet
Model/Catalog Number: 31738
Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2511-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Aug 5, 2025
Brand Name: CVS Honey Pad
Product Name: CVS Honey Pad
Model/Catalog Number: 9370613, 937404
Product Description: Infused with natural medical-grade honey
Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.Recall #Z-2512-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Jun 2, 2025
Medshape Universal Joints, REF: DNE-9000-UJ
Reason: Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Root cause: Process control
Recalling firm: Medshape, INC.Type: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.Recall #Z-2513-2025
Open, ClassifiedPosted Sep 3, 2025·Initiated Jun 25, 2025
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Reason: Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Root cause: Process control
Recalling firm: Preat CorpType: Abutment, Implant, Dental, EndosseousDistribution: US Nationwide distribution in the states of NY, FL, PA, CA, OH.Recall #Z-2514-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2454-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2455-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
IDM-MICRO-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2456-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2457-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2458-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Root cause: Device Design
Recalling firm: mo-Vis BVBAType: Components, WheelchairDistribution: US Nationwide distribution in the state of TX.Recall #Z-2459-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jun 6, 2025
Superion IDS Kit
Superion Indirect Decompression System 8MM, VF Implant
101-9808
00884662000529
Superion Indirect Decompression System 10MM, VF Implant
101-9810
00884662000536
Superion Indirect Decompression System 12MM, VF Implant
101-9812
00884662000543
Superion Indirect Decompression System 14MM, VF Implant
101-9814
00884662000550
Superion Indirect Decompression System 16MM, VF Implant
101-9816
00884662000567
Superion Indirect Decompression System Kit, VF Instrument
102-9800
00884662000574
The Vertiflex Procedure Instrument Platform, VF Instrument
140-9800
00884662000611
The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.
Reason: As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
Root cause: Device Design
Recalling firm: Boston Scientific Neuromodulation CorporationType: Prosthesis, Spinous Process Spacer/PlateDistribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.Recall #Z-2485-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Jul 22, 2025
RefleXion X1 Model RXM1000
UDI Codes:
(01)00860003983812(11)230504(21)X11001
(01)00860003983812(11)230518(21)X11002
(01)00860003983812(11)230505(21)X11003
(01)00860003983812(11)230530(21)X11004
(01)00860003983812(11)230811(21)X11006
(01)00860003983812(11)230410(21)X11007
(01)00860003983812(11)230803(21)X11008
(01)00860003983812(11)240528(21)X11009
(01)00860003983812(11)240820(21)X11010
(01)00860003983812(11)241107(21)X11011
(01)00860003983812(11)241206(21)X11012
The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography
detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.
Reason: Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
Root cause: Software change control
Recalling firm: Reflexion Medical, Inc.Type: Fludeoxyglucose F18-Guided Radiation Therapy SystemDistribution: U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.Recall #Z-2486-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 7, Software Version: 7.0.0.19.
2. RayStation 8A, Software Version: 8.0.0.61.
3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2487-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 8B, Software Version: 8.1.0.47.
2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8.
3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5.
4. RayStation 9A, Software Version: 9.0.0.113.
5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2488-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 9B, Software Version: 9.1.0.933.
2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483.
3. RayStation 10A, Software Version: 10.0.0.1154.
4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52.
5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2489-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 10B, Software Version: 10.1.0.613.
2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2490-2025
Open, ClassifiedPosted Sep 2, 2025·Initiated Aug 8, 2025
RayStation with the following product descriptions:
1. RayStation 11A, Software Version: 11.0.0.951.
2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29.
3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116.
4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15.
Product Description: Radiation Therapy Treatment Planning System.
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.Recall #Z-2491-2025