Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 13, 2026
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 790-09KIT);
5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT);
6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT);
7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT);
8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT);
9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT);
10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT);
11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).
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 Nebulizer KitDistribution: Worldwide distribution - US Nationwide and the country of Panama.Recall #Z-2993-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 8, 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) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D;
5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A;
6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296;
7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006;
8) SINUS, Medline Kit SKU DYNJ900537D;
9) SINUS, Medline Kit SKU DYNJ900537F;
10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F;
11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G;
12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I;
13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J;
14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.Recall #Z-2994-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 8, 2026
Medline medical convenience kits, labeled as:
1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545;
2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A;
3) ENT SINUS PACK, Medline Kit SKU DYNJ89001;
4) THYROID ENT, Medline Kit SKU DYNJ908641.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.Recall #Z-2995-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 8, 2026
Medline medical convenience kits, labeled as:
1) NEURO CDS, Medline Kit SKU CDS985246J;
2) NEURO PACK, Medline Kit SKU DYNJ32770V;
3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D;
4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D;
5) NEURO PACK, Medline Kit SKU DYNJ45121I;
6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A;
7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A;
8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.Recall #Z-2996-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 8, 2026
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.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.Recall #Z-2997-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 14, 2026
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as:
1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081;
2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101;
3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121;
4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141;
5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084;
6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104;
7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124;
8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144;
9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164;
10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124;
11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144;
12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.
Reason: Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
Root cause: Process control
Recalling firm: Hollister UlcType: Catheter, UrethralDistribution: US Nationwide distribution.Recall #Z-2998-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 10, 2026
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Reason: Component labeling discrepancy
Root cause: Labeling Change Control
Recalling firm: Medline Industries, LPType: Tracheobronchial Suction Catheter KitDistribution: US Nationwide distribution in the state of California.Recall #Z-2999-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jun 29, 2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Reason: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IA, OH.Recall #Z-3000-2026 Open, ClassifiedPosted Aug 21, 2026·Initiated Jun 29, 2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Reason: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IA, OH.Recall #Z-3001-2026 Open, ClassifiedPosted Aug 21, 2026·Initiated Jun 29, 2026
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Reason: The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IA, OH.Recall #Z-3002-2026 Open, ClassifiedPosted Aug 21, 2026·Initiated Jun 29, 2026
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Reason: The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IA, OH.Recall #Z-3003-2026 Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 22, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Reason: Software issue may cause measurements to be displayed inaccurately.
Root cause: Software Design Change
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.Recall #Z-3004-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Brand Name: Halyard
Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK
Model/Catalog Number: SAMM064-27
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3005-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3006-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3007-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3008-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3009-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3010-2026
Open, ClassifiedPosted Aug 21, 2026·Initiated Jul 9, 2026
Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03
Reason: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Root cause: Labeling Change Control
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MS, TX.Recall #Z-3011-2026
Open, ClassifiedPosted Aug 20, 2026·Initiated Jul 9, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Reason: Potential for arterial sheath tip separation or partial tip separation during use.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Temporary Carotid Catheter For Embolic CaptureDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, JamaicaRecall #Z-2977-2026