Recall

All recalls8,501 total

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Medline Industries, LP — MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

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.

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Medline Industries, LP — MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

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.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

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.

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Medline Industries, LP — 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 D

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.

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Medline Industries, LP — 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

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.

M
Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808

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.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

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.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VA

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.

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Medline Industries, LP — 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

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.

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Medline Industries, LP — MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C

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.

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Medline Industries, LP — 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 reca

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.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products

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.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Pina Colada, 1 Bar (81.7 g), with UPC 710594511225

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

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D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Rompope, 4 oz (85 g), with UPC 710594511812

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Tamarindo, 1 Bar (81.7 g), with UPC 827912008593

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Vainilla, 4 oz (85 g), with UPC 710594511829

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Guayaba, 1 Bar (81.7 g), with UPC 827912008432

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Arroz con Leche, 4 oz (85 g), with UPC 710594511843

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Limon, 4 oz (85 g), with UPC 710594511836

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Fresa Leche, 4 oz (85 g), with UPC 710594511850

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

D
D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

S
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INSPIREMD Inc — Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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INSPIREMD Inc — Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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INSPIREMD Inc — CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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GE Medical Systems, LLC — Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

P
Philips North America Llc — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

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INSPIREMD Inc — CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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INSPIREMD Inc — Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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