Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G;
2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J;
3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2500-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B;
2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219;
3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B;
4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B;
5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F;
6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G;
7) OB PACK, Medline Kit Number/SKU DYNJ03387B;
8) OB PACK, Medline Kit Number/SKU DYNJ03387C;
9) OB PACK, Medline Kit Number/SKU DYNJ53543B;
10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D;
11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F;
12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G;
13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K;
14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L;
15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Labor And Delivery KitDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2501-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Pelvic Exam KitDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2502-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as
BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2503-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C;
2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Cesarean Section TrayDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2504-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Hysterectomy KitDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2505-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Obstetrical KitDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2506-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I;
2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J;
3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K;
4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L;
5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M;
6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480;
7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080;
8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Eye TrayDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2507-2026
Open, ClassifiedPosted Jun 17, 2026·Initiated May 4, 2026
MEDLINE Medical Procedure Kits labeled as:
1) CRANI, Medline Kit Number/SKU DYNJ908097;
2) CRANI, Medline Kit Number/SKU DYNJ908097A;
3) CRANI, Medline Kit Number/SKU DYNJ908097B;
4) CRANI, Medline Kit Number/SKU DYNJ908097C;
5) CRANI, Medline Kit Number/SKU DYNJ908097D;
6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029;
7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B;
8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A;
9) LAMI PACK, Medline Kit Number/SKU DYNJ67767;
10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F;
11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q;
12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.Recall #Z-2508-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated May 18, 2026
Philips MultiDiagnost Eleva with the following Model Numbers:
Model # 708032 for MultiDiagnost Eleva;
Model # 708034 for MultiDiagnost Eleva with Flat Detector;
Model # 708036 for MultiDiagnost Eleva;
Model # 708037 for MultiDiagnost Eleva with Flat Detector;
Model # 708038 for MultiDiagnost Eleva with Flat Detector.
Reason: Philips Allura Xper and MultiDiagnost-Eleva systems
Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended
radiation exposure and additional contrast injection
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: System, X-Ray, AngiographicDistribution: US and ROW.Recall #Z-2411-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated May 18, 2026
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
Reason: Philips Allura Xper and MultiDiagnost-Eleva systems
Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended
radiation exposure and additional contrast injection
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US and ROW.Recall #Z-2412-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated Mar 16, 2026
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Reason: Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Root cause: Process control
Recalling firm: Smith & Nephew, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: International distribution to the countries of BE, DE, IT.Recall #Z-2456-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated May 8, 2026
Ritmed Neurological Sponges, Description/REF:
0.5x0.5in, Non-Sterile/55992C;
0.5x1.0in, Non-Sterile/55993C;
0.5x3.0in, Non-Sterile/55994C;
0.75x0.75in, Non-Sterile/55995C;
1.0x1.0in, Non-Sterile/55996C;
1.0x3.0in, Non-Sterile/55997C;
0.5x1.5in, Non-Sterile/55998C
Reason: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Root cause: Material/Component Contamination
Recalling firm: AMD Medicom Inc.Type: Gauze/Sponge, InternalDistribution: US: MT, NC, VA, CA, TX, OH, TN, IL, RIRecall #Z-2458-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated May 8, 2026
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Reason: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Root cause: Material/Component Contamination
Recalling firm: AMD Medicom Inc.Type: Gauze/Sponge, InternalDistribution: US: MT, NC, VA, CA, TX, OH, TN, IL, RIRecall #Z-2459-2026
Open, ClassifiedPosted Jun 16, 2026·Initiated Apr 30, 2026
directCHECK ACT-LR whole blood quality control, level 2
Model/Catalog Number: DCGLR-2
Reason: Assayed Whole blood control contains labeling with incorrect performance range.
Root cause: Process control
Recalling firm: Accriva Diagnostics, Inc.Type: Plasma, Coagulation ControlDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain.Recall #Z-2460-2026
Open, ClassifiedPosted Jun 15, 2026·Initiated May 15, 2026
HarmonyAIR A-Series Surgical Lighting System
Reason: There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Root cause: Process change control
Recalling firm: Steris CorporationType: Light, Surgical, Ceiling MountedDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.Recall #Z-2448-2026 Open, ClassifiedPosted Jun 15, 2026·Initiated May 15, 2026
HarmonyAIR A-Series Surgical Lighting System
Reason: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Root cause: Material/Component Contamination
Recalling firm: Steris CorporationType: Light, Surgical, Ceiling MountedDistribution: Worldwide - US Nationwide distribution.Recall #Z-2449-2026 Open, ClassifiedPosted Jun 15, 2026·Initiated May 15, 2026
ALYON Surgical Lighting System
Reason: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Root cause: Material/Component Contamination
Recalling firm: Steris CorporationType: Light, Surgical, Ceiling MountedDistribution: Worldwide - US Nationwide distribution.Recall #Z-2450-2026 Open, ClassifiedPosted Jun 15, 2026·Initiated May 19, 2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Navigation, Inc.-BoxboroughType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.Recall #Z-2451-2026
Open, ClassifiedPosted Jun 13, 2026·Initiated Apr 21, 2026
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Paracentesis TrayDistribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.Recall #Z-2363-2026