Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C;
2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166;
3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B;
4) EAST DAVINCI, Medline Kit SKU DYNJ900949C;
5) THORACIC, Medline Kit SKU DYNJ903470G;
6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G;
7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A;
8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B;
9) DIEP FLAP, Medline Kit SKU DYNJ910832A;
10) C-SECTION, Medline Kit SKU DYNJ911236;
11) LAPAROTOMY, Medline Kit SKU DYNJ911243;
12) OPEN HEART A&B, Medline Kit SKU DYNJ911245;
13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332;
14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: 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.Recall #Z-3024-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q;
2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D;
3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759;
4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781;
5) ROBOT ME RF, Medline Kit SKU DYNJ900203N;
6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q;
7) ROBOTIC, Medline Kit SKU DYNJ903485K;
8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K;
9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I;
10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B;
11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B;
12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C;
13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180;
14) GYN ROBOTIC, Medline Kit SKU DYNJ910181;
15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A;
16) ROBOTICS, Medline Kit SKU DYNJ912062.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: 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.Recall #Z-3025-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 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.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Cesarean Section TrayDistribution: 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.Recall #Z-3026-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) LAVH, Medline Kit SKU CDS982273U;
2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L;
3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q;
4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F;
5) A P RESECTION, Medline Kit SKU DYNJ903467L.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Hysterectomy KitDistribution: 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.Recall #Z-3027-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 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 SKU DYNJ906804B;
4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Obstetrical KitDistribution: 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.Recall #Z-3028-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 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 DYNJ903471I;
4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: 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.Recall #Z-3029-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 22, 2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Reason: Software issue may cause the ruler measurement to be inaccurate.
Root cause: Software design
Recalling firm: FUJIFILM Healthcare Americas CorporationType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.Recall #Z-3030-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 29, 2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
Root cause: Under Investigation by firm
Recalling firm: Healthmark Industries Co., Inc.Type: Qualitative Cleaning Process Protein IndicatorDistribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.Recall #Z-3031-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 29, 2026
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
Root cause: Under Investigation by firm
Recalling firm: Healthmark Industries Co., Inc.Type: Qualitative Cleaning Process Protein IndicatorDistribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.Recall #Z-3032-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Aug 6, 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
Reason: 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 rotational movement occurs during a procedure.
Root cause: Nonconforming Material/Component
Recalling firm: IMRIS Imaging IncType: Table, Operating-Room, Ac-PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.Recall #Z-3033-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Aug 6, 2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Reason: 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 rotational movement occurs during a procedure.
Root cause: Nonconforming Material/Component
Recalling firm: IMRIS Imaging IncType: Table, RadiologicDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.Recall #Z-3034-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Aug 18, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.
GEI / Electrosurgical, cutting & coagulation & accessories
Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Root cause: Labeling Change Control
Recalling firm: Olympus Corporation of the AmericasType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.Recall #Z-3035-2026
Open, ClassifiedPosted Aug 25, 2026·Initiated Jul 20, 2026
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Reason: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Root cause: Software design
Recalling firm: Midmark CorporationType: ElectrocardiographDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-3012-2026 Open, ClassifiedPosted Aug 25, 2026·Initiated Jul 20, 2026
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Reason: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Root cause: Software design
Recalling firm: Midmark CorporationType: Transmitters And Receivers, Physiological Signal, RadiofrequencyDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-3013-2026 Open, ClassifiedPosted Aug 25, 2026·Initiated Aug 4, 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 system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason: 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.
Root cause: Process control
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.Recall #Z-3014-2026
Open, ClassifiedPosted Aug 25, 2026·Initiated Jul 9, 2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes:
1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429
2) 114-3934, Mfr Product Code 1480; Lot 2539064
3) 114-3935, Mfr Product Code 1481; Lot 2533123
4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.
Reason: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Root cause: Process control
Recalling firm: Henry Schein Inc.Type: Material, Tooth Shade, ResinDistribution: Worldwide distribution - US Nationwide and the country of Barbados.Recall #Z-3015-2026
Open, ClassifiedPosted Aug 25, 2026·Initiated Jul 9, 2026
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes:
1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145
2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065
3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099
4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.
Reason: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Root cause: Process control
Recalling firm: Henry Schein Inc.Type: Material, Tooth Shade, ResinDistribution: Worldwide distribution - US Nationwide and the country of Barbados.Recall #Z-3016-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jun 26, 2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Reason: Potential of failing to trigger clinical scan during Bolus Tracking.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.Type: System, X-Ray, Tomography, ComputedDistribution: U.S. Nationwide and U.S. Territories distribution.Recall #Z-2988-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 13, 2026
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Reason: 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. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Humidifier, Respiratory Gas, (Direct Patient Interface)Distribution: Worldwide distribution - US Nationwide and the country of Panama.Recall #Z-2991-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 13, 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-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09);
3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13);
4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14);
5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15);
6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).
Reason: 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. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Set, Tubing And Support, Ventilator (W Harness)Distribution: Worldwide distribution - US Nationwide and the country of Panama.Recall #Z-2992-2026