Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
TAVR PACK DYNJ69246B
ABDOMINAL VASCULAR-LF DYNJ905291D
ANGIOGRAPHIC PACK DYNJ86769
AORTAGRAM PACK DYNJ26783D
AV FISTULA PACK CHS-LF DYNJ35615G
AV SHUNT PACK-LF DYNJ0842516G
CATHETER PACK DYNJ61926
EP DRAPE PACK-LF DYNJ47645C
EP PACK DYNJ47782G
EPS ACCESSORY PACK DYNJT2201S
H CLINIC VASCULAR PK DYNJ33415A
HEART FAILURE PACK DYNJ64877B
HYBRID PACK DYNJ65925D
INTERVENTIONAL RAD PACK DYNJ44100M
INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG
MV-PACEMAKER PACK-LF DYNJ41556F
NEURO RADIOLOGY RICHMOND DYNJ68365D
OR HYBRID-M DYNJ907758D, DYNJ907758F
PACEMAKER DYNJ907960C
PACEMAKER PACK DYNJ42557B
DYNJ61411
DYNJ61411A
DYNJ61411B
DYNJ80160
PACER PACK DYNJ40952B
PERIPHERAL ARTERIOGRAM RAD DYNJ61383B
RADIOLOGY PACK DYNJ54762D
TAVR PACK DYNJ55338B
DYNJ69246A
VASCULAR ACCESS TRAY DYNJ52606F
VASCULAR TRAY DYNJ49802C
VEIN PACK DYNJ57512
DYNJ58063
DYNJ84953
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1878-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BIOPSY PACK DYNJ38587A, DYNJ38587B
BIOPSY/DRAINAGE TRAY-LF DYNJ30078D
W LINQ PACK DYNJ59108B
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Ct Biopsy TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1879-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
MINOR ENT SINUS PACK-LF
DYNJ0101278F
DYNJ0101278G
DYNJ0101278I
SINUS PACK DYNJ56262
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1880-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BARIATRIC DYNJ905153M, DYNJ905153N
GENERAL LAPAROSCOPY PACK DYNJ81602
LAPAROSCOPY DYNJ905157K, DYNJ905157L
LAPAROTOMY PACK DYNJ46675G
MAJOR LITHOTOMY PACK DYNJ81607
MAJOR PLUS PACK DYNJ905160O
MINOR GENERAL PACK DYNJ81599
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Laparoscopy KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1881-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FACE/RHINOPLASTY PACK DYNJ80343C
PLASTIC HEAD-NECK PACK DYNJ86639
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Plastic Surgery And Accessories KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1882-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BASIC CL PACK-LF DYNJ87052
BASIC PACK DYNJ83976
BASIC SET UP PACK DYNJ80700
CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B
CSTM ANGIO KIT - S VASC1109
CV PACK DYNJ46301C
DR F PACK DYNJ41253B
ENSEMBLE HEMORROIDES DYNJ56311A
G TAVR PACK DYNJ61006
IR MINOR PACK DYNJ44139C
MAJOR PLUS PACK DYNJ905160N
MAXIMUM BARRIER BUNDLE PACK DYNJ35216C
PCI PACK TBRHSC-LF DYNJ41941D
PERC PACK-LF DYNJ0774759P
PERIPHERAL ANGIOGRAPHY PK DYNJ42094B
PROCEDURE PACK DYNJ55063B
PTCA PACK DYNJ55359B
ROBOTIC PACK DYNJ908706C
SPECIAL PROCEDURES TRAY DYNJ41174A
SYRINGE WIRE KIT SANFORD SAMPC0644
WPH EP PACK DYNJ62745
X-RAY PACK DYNJ44295G
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1883-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ANGIO KIT PACK DYNJ50783B
ANGIO PHC DYNJ37485C
C.I.C.N. ANGIO PACK DYNJ53064B
FHT P NEURO PACK DYNJ39931D
NEURO ARTERIOGRAM PACK-LF DYNJ0948060F
NEURO KIT NAM0003
NEURO PACK DYNJ61542D
NEURO RADIOLOGY PACK DYNJ59903B
NEURO TRAY DYNJ84872A
PK, CATH LAB-ANGIO DYNJ44027F
QVH IR NEURO PACK DYNJ62176
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1884-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
GU DAVINCI PACK - LF DYNJ909398A
ROBOTIC PACK DYNJ908706D
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1885-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
EYE PACK DYNJ35056A
HEART CATH PACK DYNJ69318A
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Eye TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1886-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
EXTREMITY PACK DYNJ34846C
HAND PACK DYNJ83218A, DYNJ85396
LAMINECTOMY DYNJ905156R
MAJOR EXTREMITY DYNJ905159L, DYNJ905159M
MAJOR EXTREMITY PACK DYNJ69926A
PODIATRY PACK DYNJ41250B
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1887-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ARTHROSCOPY PACK DYNJ45173D
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Arthrogram TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1888-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
E P DRAPE PACK-LF DYNJ0373061J
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Drape, Surgical, AntimicrobialDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1889-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M
ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K
ANGIO KIT PACK DYNJ83746B
ANGIO TRAY NO LIDO DYNJ85557A
ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T
ARTERIOGRAM NEURO PACK-LF DYNJ0842499L
ARTERIOGRAM PACK-LF DYNJ0842478M
CARDIAC CATH II PK DYNJ21259O
CARDIAC CATH PACK DYNJ68653D
CATH LAB ANGIOGRAPHY PACK DYNJ50779G
CATH LAB-LF DYNJ51423G
CRANIOTOMY PACK-LF DYNJ0101292I
DEEP BRAIN STIMULATION PACK DYNJ0842793I
ENDO VASCULAR MINOR DYNJ87263
GENERAL ENDO PACK-LF DYNJ0842873L
LEFT HEART DYNJ45984J
LIPO PACK DYNJ87218
MAA Y90 TRAY DYNJ82191D
MAIN OR CATH LAB DYNJ61373B
MINIMALLY INVASIVE PACK-LF DYNJ0843063M
NEURO CERVICAL PACK DYNJ0101287M
NEURO RADIOLOGY RICHMOND DYNJ68365F
NEURO VP SHUNT PACK-LF DYNJ0843121L
NON-VASCULAR PACK DYNJ56386C, DYNJ56386D
OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B
OR RADIOLOGY PACK DYNJ62747A
PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J
PERIPHERAL ARTERIOGRAM RAD DYNJ61383C
PICC ABSCESS PACK-LF DYNJ0774005I
PICC TRAY DYNJ30554I
PODIATRY PACK DYNJ46333G
POSTERIOR SPINE PACK-LF DYNJ0843339P
RRMC ANGIO PACK DYNJ36338D
SPECIAL PROCEDURE PACK DYNJ88258
VASCULAR ACCESS PACK-LF DYNJ0101291G
VASCULAR HYBRID DYNJ57543K
VASCULAR PACK DYNJ82220D
VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M
WPH EP PACK DYNJ62745A
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1890-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ARTERIOGRAM TRAY 00-402001T, 00-402001U
CATH LAB-VEIN PROCEDURES DYNJ60329A
CENTRAL VENOUS ACCESS PACK-LF CVI5070
FISTULAGRAM PACK DYNJ66259
INVASIVE LINE INSERTION DYNJ44123C
NON VASCULAR PACK DYNJ68037B, DYNJ68037C
PICC ABSCESS PACK-LF DYNJ0774005G
PICC LINEPACK (PCLUI)642-LF DYNJ47717B
PICC PHC DYNJ37484C
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Central Venous Catheter TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1891-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Feb 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B
LAVH GRH-LF DYNJ41792G
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Root cause: Component change control
Recalling firm: Medline Industries, LPType: Hysterectomy KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.Recall #Z-1892-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 13, 2026
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ;
Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits);
The LeadCare II kit is provided with the following materials:
" Sensors (2 Containers of 24 sensors each; 48 tests)
" Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests)
" Heparinized Capillary Tubes/Plungers (50 @)
" Transfer Droppers (50 @)
" Calibration Button (1 @)
" Lead Control Level 1 (1 @ 2 mL)
" Lead Control Level 2 (1 @ 2 mL)
Reason: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Root cause: Device Design
Recalling firm: Magellan Diagnostics, Inc.Type: Lead, Atomic AbsorptionDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.Recall #Z-1893-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 13, 2026
LeadCare Plus Blood Lead Test Kit;
Catalog Number: 82-0004;
The LeadCare Plus kit is provided with the following materials:
" Sensors (4 containers of 24 each; 96 tests)
" Treatment Reagent Tubes (4 packages of 24 each; 96 tests)
" Calibration Button (1 @)
" Lead Control Level 1 (1 @ 2 mL)
" Lead Control Level 2 (1 @ 2 mL)
Reason: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Root cause: Device Design
Recalling firm: Magellan Diagnostics, Inc.Type: Lead, Atomic AbsorptionDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.Recall #Z-1894-2026
Open, ClassifiedPosted Apr 17, 2026·Initiated Mar 13, 2026
LeadCare Ultra Blood Lead Test Kit;
Catalog Number: 70-8098;
The LeadCare Ultra kit is provided with the following materials:
" Sensors (8 containers of 24 each; 192 tests)
" Treatment Reagent Tubes (8 containers of 24 each; 192 tests)
" Calibration Button (1 @)
" Lead Control Level 1 (1 @ 2 mL)
" Lead Control Level 2 (1 @ 2 mL)
Reason: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Root cause: Device Design
Recalling firm: Magellan Diagnostics, Inc.Type: Lead, Atomic AbsorptionDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.Recall #Z-1895-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 12, 2026
ARTIS Pheno VE30A and VE40A, Model 10849000
Reason: During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: U.S. and O.U.S.Recall #Z-1814-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated May 16, 2025
Brand Name: Cellex Photopheresis System
Product Name: CELLEX Photopheresis Kit
Model/Catalog Number: CLXUSA
Software Version: Not Applicable
Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a
photoimmune therapy where leukocytes are separated from whole blood
via apheresis, combined with a photoactive drug (8-methoxypsoralen) and
then exposed to ultraviolet A (UVA) light. All blood components, including
the treated leukocytes, are returned to the patient.
THERAKOS Photopheresis utilizes the THERAKOS CELLEX System to
combine cell separation and photoactivation into a single, closed and sterile
circuit. The THERAKOS CELLEX Photopheresis System collects the buffy
coat (leukocyte-enriched blood) from the patient in a discontinuous flow
process and intermittently returns the remaining plasma and erythrocytes to
the patient. The buffy coat is passed through the photoactivation module
where the drug is activated with a precise amount of UVA light determined
by the characteristics of the individual patient s buffy coat. After
photoactivation, the buffy coat is immediately returned to the patient s
bloodstream.
Component: Not Applicable
Reason: Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Root cause: Process control
Recalling firm: THERAKOS DEVELOPMENT LIMITEDType: System, Photopheresis, ExtracorporealDistribution: US Nationwide distribution.Recall #Z-1822-2026