|
|
FDA
Z-3027-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |
|
|
FDA
Z-3032-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 29, 2026
|
Details |
|
|
FDA
Z-3021-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |
|
|
FDA
Z-2988-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jun 26, 2026
|
Details |
|
|
FDA
Z-3030-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 22, 2026
|
Details |
|
|
FDA
Z-3001-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jun 29, 2026
|
Details |
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
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.
|
FDA
Z-2997-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 8, 2026
|
Details |
|
|
FDA
Z-2995-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 8, 2026
|
Details |
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Kits contain a potentially contaminated component which were recalled by the manufacturer
|
FDA
Z-3020-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |
|
|
FDA
Z-3007-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 9, 2026
|
Details |
|
|
FDA
Z-3012-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 20, 2026
|
Details |
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 ROBO
Kits contain a potentially contaminated component which were recalled by the manufacturer
|
FDA
Z-3025-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |
|
|
FDA
Z-3031-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 29, 2026
|
Details |
|
|
FDA
Z-3018-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 14, 2026
|
Details |
|
|
FDA
Z-3008-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 9, 2026
|
Details |
|
|
FDA
Z-3039-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 20, 2026
|
Details |
|
|
FDA
Z-3019-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |
|
|
FDA
Z-3010-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 9, 2026
|
Details |
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-0
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.
|
FDA
Z-2993-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 13, 2026
|
Details |
|
|
FDA
Z-3009-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 9, 2026
|
Details |
|
|
FDA
Z-3015-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 9, 2026
|
Details |
|
|
FDA
Z-2996-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 8, 2026
|
Details |
|
|
FDA
Z-3013-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 20, 2026
|
Details |
|
|
FDA
Z-2998-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 14, 2026
|
Details |
|
|
FDA
Z-2999-2026
|
Medical Device |
High |
Sep 2, 2026
Recall: Jul 10, 2026
|
Details |