Class II
Ongoing
Reported Sep 2, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Firm
- Olympus Corporation of the Americas
- Recall began
- Aug 18, 2026
- Quantity
- 335 units
- Codes
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- FDA IDs
- Z-3035-2026 / event 99607
Class II
Ongoing
Reported Sep 2, 2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rota...
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Firm
- IMRIS Imaging Inc
- Recall began
- Aug 6, 2026
- Quantity
- 6 units
- Codes
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- FDA IDs
- Z-3033-2026 / event 99596
Class II
Ongoing
Reported Sep 2, 2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rota...
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Firm
- IMRIS Imaging Inc
- Recall began
- Aug 6, 2026
- Quantity
- 13 units
- Codes
- 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462,...
- FDA IDs
- Z-3034-2026 / event 99596
Class II
Ongoing
Reported Sep 2, 2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The syst...
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
- Firm
- Canon Medical System, USA, INC.
- Recall began
- Aug 4, 2026
- Quantity
- 10 systems
- Codes
- Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC241...
- FDA IDs
- Z-3014-2026 / event 99222
Class II
Ongoing
Reported Sep 2, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Software issue may cause measurements to be displayed inaccurately.
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Firm
- Merge Healthcare, Inc.
- Recall began
- Jul 22, 2026
- Quantity
- 20 units
- Codes
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- FDA IDs
- Z-3004-2026 / event 99520
Class II
Ongoing
Reported Sep 2, 2026
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CI...
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. D...
Worldwide distribution - US Nationwide and the country of Panama.
- Firm
- Medline Industries, LP
- Recall began
- Jul 13, 2026
- Quantity
- 145525 units
- Codes
- 1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Disc...
- FDA IDs
- Z-2992-2026 / event 99403
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ9...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 94 kits
- Codes
- Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case),...
- FDA IDs
- Z-3022-2026 / event 99507
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 106 kits
- Codes
- Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case...
- FDA IDs
- Z-3026-2026 / event 99507
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SK...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 419 kits
- Codes
- Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case)...
- FDA IDs
- Z-3028-2026 / event 99507
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ9034...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 241 kits
- Codes
- Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case),...
- FDA IDs
- Z-3029-2026 / event 99507
Class II
Ongoing
Reported Sep 2, 2026
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) E...
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
- Firm
- Medline Industries, LP
- Recall began
- Jul 8, 2026
- Quantity
- 2262 kits
- Codes
- Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case...
- FDA IDs
- Z-2994-2026 / event 99489
Class II
Ongoing
Reported Sep 2, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
US Nationwide distribution.
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Recall began
- Jun 30, 2026
- Quantity
- 1140 systems
- Codes
- 191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5...
- FDA IDs
- Z-3017-2026 / event 99438