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
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 23, 2026
Gentuity HF-OCT Imaging System Model G10-01;
Software version 23.2.13;
Reason: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Root cause: Device Design
Recalling firm: Gentuity, LLCType: Catheter, Intravascular, DiagnosticDistribution: Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX;
International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;Recall #Z-1823-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 16, 2026
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Reason: On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the state of South Carolina.Recall #Z-1824-2026
Open, ClassifiedPosted Apr 16, 2026·Initiated Mar 7, 2026
Philips Spectral CT on Rails. Model Number: 728334.
Reason: Philips has identified three software issues:
1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go.
2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear.
3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.Recall #Z-1825-2026
Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model Number: SL-2010M2096A.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1798-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1799-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1800-2026 Open, ClassifiedPosted Apr 15, 2026·Initiated Mar 19, 2026
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Root cause: Device Design
Recalling firm: B Braun Medical IncType: Set, Tubing, Blood, With And Without Anti-Regurgitation ValveDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1801-2026