Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 14, 2025
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation,
manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Root cause: Component change control
Recalling firm: GE Medical Systems China Co., Ltd.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.Recall #Z-0915-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 6, 2025
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Reason: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
Root cause: Component change control
Recalling firm: PATHType: Stimulator, Auditory, Evoked ResponseDistribution: Domestic: WI.
International: Ireland.Recall #Z-0940-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 18, 2025
Intelerad InteleShare software, with ProViewer component
Reason: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
Root cause: Software design
Recalling firm: DICOM Grid, Inc.Type: System, Image Processing, RadiologicalDistribution: US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE
OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SERecall #Z-0941-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Oct 29, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*
*Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Root cause: Under Investigation by firm
Recalling firm: Copan ItaliaType: General Purpose ReagentDistribution: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UTRecall #Z-0942-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Oct 29, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Reason: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Root cause: Under Investigation by firm
Recalling firm: Copan ItaliaType: General Purpose ReagentDistribution: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UTRecall #Z-0943-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Silicone Carving Implant
Product Name: Silicone Carving Implant
Model/Catalog Numbers:
600-601 - Silicone Carving Implant Style 6 Size 1
UDI-DI code: B490600601
600-602 - Silicone Carving Implant Style 6 Size 2
UDI-DI code: B490600602
600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs
UDI-DI code: B4906006019
600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs
UDI-DI code: B4906006039
600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs
UDI-DI code: B4906006049
600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs
UDI-DI code: B49060060239
600-603 -Silicone Carving Implant Style 6 Size 3
UDI-DI code: B490600603
600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs
UDI-DI code: B49060060339
600-604 - Silicone Carving Implant Style 6 Size 4
UDI-DI code: B490600604
600-605 - Silicone Carving Implant Style 6 Size 5
UDI-DI code: B490600605
600-801 - Silicone Carving Implant Style 8 Size 1
UDI-DI code: B490600801
600-803 - Silicone Carving Implant Style 8 Size 3
UDI-DI code: B490600803
600-804 - Silicone Carving Implant Style 8 Size 4
UDI-DI code: B490600804
Intended for Augmentation and reconstructive surgery.
* Pending information
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Elastomer, Silicone BlockDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0944-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Gluteal Implant
Product Name: Gluteal Implant
Model/Catalog Numbers:
501-101 - Gluteal Implant style 1 size 1
UDI-DI code: B490501101
501-103 - Gluteal Implant style 1 size 3
UDI-DI code: B490501103
501-101
UDI-DI code: B490501101
501-103 - Gluteal Implant style 1 size 3
UDI-DI code: B490501103
501-105 - Gluteal Implant style 1 size 5
UDI-DI code: B490501105
501-206 - Gluteal Implant style 2 size 6
UDI-DI code: B490501206
501-301 - Gluteal Implant style 3 size 1
UDI-DI code: B490501301
501-302 - Gluteal Implant style 3 size 2
UDI-DI code: B490501302
501-303 - Gluteal Implant style 3 size 3
UDI-DI code: B490501303
501-304 - Gluteal Implant style 3 size 4
UDI-DI code: B490501304
501-305 - Gluteal Implant style 3 size 5
UDI-DI code: B490501305
501-306 - Gluteal Implant style 3 size 6
UDI-DI code: B490501306
501-307 - Gluteal Implant style 3 size 7
UDI-DI code: B490501307
501-309 - Gluteal Implant style 3 size 9
UDI-DI code: B490501309
501-310 - Gluteal Implant style 3 size 10
UDI-DI code: B490501310
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Elastomer, Silicone BlockDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0945-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Chin Implant
Product Name: Chin Implant
Model/Catalog Numbers:
400-0101 Chin Implant style 1 size 1
UDI-DI code: B490400101
400-0103 Chin Implant style 1 size 3
UDI-DI code: B490400103
400-0104 Chin Implant style 1 size 4
UDI-DI code: B490400104
400-0201 Chin Implant style 2 size 1
UDI-DI code: B490400201
400-0202 Chin Implant style 2 size 2
UDI-DI code: B490400202
400-0301 Chin Implant style 3 size 1
UDI-DI code: B49044301
400-0302 Chin Implant style 3 size 2
UDI-DI code: B490400302
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Prosthesis, Chin, InternalDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0946-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Malar Implant
Product Name: Malar Implant
Model/Catalog Number:
401-202-5 Malar Implant style 2 size 2 left
UDI-DI code: B4904012025
401-202-6 Malar Implant style 2 size 2 right
UDI-DI code: B4904012026
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Implant, MalarDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0947-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Pectoral Implant
Product Name: Pectoral Implant
Model/Catalog Number:
500-106-5 Pectoral Implant style 1 size 6 left
UDI-DI code: B4905001065
500-106-6 Pectoral Implant style 1 size 6 right
UDI-DI code: B4905001066
500-200-5 Pectoral Implant style 2 size 0 left
UDI-DI code: B4950020205
500-200-6
500-201-5
500-201-6
500-202-5
500-202-6
500-403-5
500-403-6
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Implant, Muscle, PectoralisDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0948-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Sep 26, 2025
Brand Name: AART Calf Implant
Product Name: Calf Implant
Model/Catalog Number:
502-103 - Calf Implant style 1 size 3
UDI-DI code: B490502103
502-104 - Calf Implant style 1 size 4
UDI-DI code: B490502104
502-105 - Calf Implant style 1 size 5
UDI-DI code: B490502105
502-106 - Calf Implant style 1 size 6
UDI-DI code: B490502106
502-201 - Calf Implant style 2 size 1
UDI-DI code: B490502201
502-303 - Calf Implant style 3 size 3
UDI-DI code: B490502303
502-304 - Calf Implant style 3 size 4
UDI-DI code: B490502304
Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause: No Marketing Application
Recalling firm: DSAART LLCType: Elastomer, Silicone BlockDistribution: U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI
O.U.S.: N/ARecall #Z-0949-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-12-PK
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Component: N/A
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0950-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-12-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Component: N/A
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0951-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54544-18-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Component: N/A
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0952-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard
Model/Catalog Number: R54544-18-SG
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0953-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-16-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Component: N/A
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0954-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 7, 2025
Brand Name: Rocket
Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray
Model/Catalog Number: R54549-20-PK
Software Version: N/A
Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
Component: N/A
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Root cause: Labeling design
Recalling firm: Rocket Medical PlcType: Catheter, IrrigationDistribution: Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX;
International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South AfricaRecall #Z-0955-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Oct 9, 2025
Myosa for Kids
KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc
KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc
Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to
address breathing and myofunctional disorders.
Catalog Numbers:
Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Root cause: No Marketing Application
Recalling firm: Myofunctional Research Company USAType: Device, Anti-SnoringDistribution: U.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL, GA, HI, IL, KS, KY, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, and WA; O.U.S. (foreign) to country of: AustraliaRecall #Z-0956-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason: Removal of affected lot of screws due to labeling error.
Root cause: Packaging process control
Recalling firm: Smith & Nephew, Inc.Type: Screw, Fixation, BoneDistribution: US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.Recall #Z-0957-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 13, 2025
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Reason: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
Root cause: Software Design Change
Recalling firm: Medtronic MiniMed, Inc.Type: Calculator, Drug DoseDistribution: US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM.
OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United KingdomRecall #Z-0958-2026