Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 6, 2025
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Root cause: Process control
Recalling firm: Abbott MedicalType: Stimulator, Electrical, Implanted, For Parkinsonian TremorDistribution: Worldwide distribution.Recall #Z-0459-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Aug 22, 2025
Brand Name: Sonesta
Product Name: 6210
Model/Catalog Number: 0120-LA120-03
Software Version: N/A
Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures.
Component: N/A
Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Root cause: Process control
Recalling firm: Sonesta Medical ABType: Table, Radiographic, TiltingDistribution: US Distribution to NH only.Recall #Z-0460-2026 Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
ProxiDiagnost N90;
Model Number: 706110;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: System, X-Ray, Fluoroscopic, Image-IntensifiedDistribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0461-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
CombiDiagnost R90;
Model Number: 709031;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: System, X-Ray, Fluoroscopic, Image-IntensifiedDistribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0462-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Precision CRF;
Model Number: 706400;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: System, X-Ray, Fluoroscopic, Image-IntensifiedDistribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0463-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value;
Model Number: (1) 712031, (2) 712032;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0464-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER;
Model Number: (1) 712034, (2) 712035;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: Solid State X-Ray Imager (Flat Panel/Digital Imager)Distribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0465-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Radiography 7300 C;
Model Number: 712037;
Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potential manufacturing issues.
Root cause: Device Design
Recalling firm: Philips Medical Systems DMC GmbHType: System, X-Ray, StationaryDistribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,Recall #Z-0466-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version
4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0467-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0468-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0469-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10
Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0470-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0471-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0472-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0473-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0474-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0475-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0476-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 1, 2025
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Reason: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-0477-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 19, 2025
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.
2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035.
3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040.
4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045.
5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050.
6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030.
7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035.
8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040.
9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045.
10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050.
11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055.
12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060.
13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030.
14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035.
15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040.
16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045.
17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050.
18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055.
19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060.
20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035.
21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040.
22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045.
23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050.
24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055.
25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.
Reason: Polyaxial screws do not meet performance standards.
Root cause: Process change control
Recalling firm: Orthofix U.S. LLCType: Thoracolumbosacral Pedicle Screw SystemDistribution: US Nationwide distribution in the states of California, North Carolina, and Texas.Recall #Z-0478-2026