Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 15, 2025
Allura Xper FD10;
Model Number: 722026;
Reason: Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
Root cause: Other
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.Recall #Z-1073-2026
Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 15, 2025
Allura Xper FD10/10;
Model Number: 722027;
Reason: Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
Root cause: Other
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.Recall #Z-1074-2026
Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 15, 2025
Allura Xper FD20;
Model Number: 722028;
Reason: Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
Root cause: Other
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.Recall #Z-1075-2026
Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 15, 2025
Allura Xper FD20/10;
Model Number: 722029;
Reason: Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
Root cause: Other
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.Recall #Z-1076-2026
Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 15, 2025
Allura Xper FD20/20;
Model Number: 722038;
Reason: Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
Root cause: Other
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.Recall #Z-1077-2026
Open, ClassifiedPosted Jan 13, 2026·Initiated Dec 10, 2025
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Reason: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Root cause: Software change control
Recalling firm: Elekta, Inc.Type: Accelerator, Linear, MedicalDistribution: US Nationwide distribution in the state of TX.Recall #Z-1078-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 21, 2025
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason: Emphasizing instructions for LVP duration programming located in the IFU.
Root cause: Use error
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.Recall #Z-1048-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US Nationwide distribution.Recall #Z-1049-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;
2) OPEN HEART CDSKit SKU CDS984355K;
3) BAG A OPEN HEART KITKit SKU DYKM1025D;
4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;
5) OPEN HEART CDSKit SKU DYNJ902879T;
6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;
7) OPEN HEART CDSKit SKU DYNJ905557B;
8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution.Recall #Z-1050-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) DELUXE PRE OP KIT, Medline SKU DYKS2034A;
2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Central Venous Catheter TrayDistribution: US Nationwide distribution.Recall #Z-1051-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R;
2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution.Recall #Z-1052-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Sewing MachineDistribution: US Nationwide distribution.Recall #Z-1053-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Plastic Surgery And Accessories KitDistribution: US Nationwide distribution.Recall #Z-1054-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B;
2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B;
3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C;
4) TOP DRAWER #6, Medline kit SKU ACC010688;
5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770;
6) SURGERY BAG, Medline kit SKU DYKM1279C;
7) ADMISSION KIT, Medline kit SKU DYKS1179;
8) PRE OP KIT, Medline kit SKU DYKS1192C;
9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B;
10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B;
11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248;
12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249;
13) PRE OP KIT, Medline kit SKU DYKS1274A;
14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324;
15) PRE OP KIT, Medline kit SKU DYKS1376;
16) PTC KIT, Medline kit SKU DYNDH1161A;
17) DR BROWN BODY, Medline kit SKU DYNJ910487.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution.Recall #Z-1055-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) IV START KIT NS, Medline kit SKU DYKM1980C;
2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B;
3) IV START KIT, Medline kit SKU DYKS1372C;
4) IV START KIT, Medline kit SKU DYNDV1691B;
5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: I.V. Start KitDistribution: US Nationwide distribution.Recall #Z-1056-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) PRE OP KIT, Medline kit SKU DYKS1093B;
2) PRE OP KIT, Medline kit SKU DYKS1124C;
3) PRE OP KIT, Medline kit SKU DYKS1128C;
4) PREOP KIT, Medline kit SKU DYKS1130B;
5) PRE OP KIT, Medline kit SKU DYKS1163G;
6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G;
7) PREOP KIT, Medline kit SKU DYKS1313A;
8) PRE OP KIT, Medline kit SKU DYKS1325A;
9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D;
10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A;
11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B;
12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B;
13) PRE OP KIT, Medline kit SKU DYKS1382A;
14) PRE OP KIT, Medline kit SKU DYKS1416F;
15) PREOP KIT, Medline kit SKU DYKS1448B;
16) PRE-OP KIT, Medline kit SKU DYKS1458F;
17) PRE OP KIT, Medline kit SKU DYKS1467B;
18) PRE OP KIT, Medline kit SKU DYKS1468;
19) PRE-OP, Medline kit SKU DYKS1482A;
20) ADULT PRE OP, Medline kit SKU DYKS1487I;
21) PRE OP ENDO, Medline kit SKU DYKS1489F;
22) PREOP KIT, Medline kit SKU DYKS1507B;
23) PRE OP KIT, Medline kit SKU DYKS1518A;
24) PRE OP KIT, Medline kit SKU DYKS1544F;
25) PREOP, Medline kit SKU DYKS1551B;
26) PREOP, Medline kit SKU DYKS1552B;
27) PREOP, Medline kit SKU DYKS1580;
28) PRE OP KIT, Medline kit SKU DYKS2024A;
29) PRE OP KIT, Medline kit SKU DYKS2056A;
30) PRE-OP KIT, Medline kit SKU DYKS2074;
31) PRE-OP KIT, Medline kit SKU DYKS2074A;
32) PREOP KIT, Medline kit SKU DYKS2076;
33) PRE OP KIT 1, Medline kit SKU DYKS2083;
34) PRE OP KIT, Medline kit SKU DYKS2103.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Skin Prep TrayDistribution: US Nationwide distribution.Recall #Z-1057-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) ADMIN KIT, Medline kit SKU DYKS1339B;
2) ADMIN KIT, Medline kit SKU DYKS1339C;
3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B;
4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Patient Personal Hygiene KitDistribution: US Nationwide distribution.Recall #Z-1058-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
NEURO ANGIO PACK, Medline kit SKU DYNJ38935
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: US Nationwide distribution.Recall #Z-1059-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 26, 2025
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V;
2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C;
3) DISCECTOMY PACK, Medline kit SKU DYNJ86770;
4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Reason: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution.Recall #Z-1060-2026
Open, ClassifiedPosted Jan 12, 2026·Initiated Nov 29, 2025
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female
REF: RTU14F
Reason: Labeling error, Incorrect expiration date
Root cause: Labeling Change Control
Recalling firm: HANGZHOU BEVER MEDICAL DEVICES CO., LTD.Type: Catheter, UrethralDistribution: US Nationwide distribution in the state of GA.Recall #Z-1061-2026