Medical Device Recalls

8,553 medical device recalls from federal enforcement feeds.

Showing 1,151–1,200 of 8,553

• Medical Device Recall · March 24, 2026

  Medline Industries, LP

  Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075;

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

  Class I

• Medical Device Recall · March 24, 2026

  ICU Medical, Inc.

  Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

  Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

  Class II

• Medical Device Recall · March 24, 2026

  Foundation Medicine, Inc.

  Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990

  Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

  Class II

• Medical Device Recall · March 24, 2026

  Medline Industries, LP

  Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO K

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

  Class I

• Medical Device Recall · March 24, 2026

  Medline Industries, LP

  Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

  Class I

• Medical Device Recall · March 24, 2026

  Medline Industries, LP

  Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

  Class I

• Medical Device Recall · March 24, 2026

  Medline Industries, LP

  Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

  Class I

• Medical Device Recall · March 23, 2026

  Advanced Bionics, LLC

  Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-550

  The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

  Class II

• Medical Device Recall · March 23, 2026

  TANGENT ENDOSCOPY, LLC

  Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

  Affected devices exhibited fractures at the distal shaft tip without complete detachment.

  Class II

• Medical Device Recall · March 23, 2026

  Olympus Corporation of the Americas

  Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

  Potential for detachment of a distal tip component of the device during use.

  Class II

• Medical Device Recall · March 23, 2026

  Gentuity, LLC

  Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

  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.

  Class II

• Medical Device Recall · March 23, 2026

  THERANICA BIOELECTRONICS LTD

  Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

  Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

  Class II

• Medical Device Recall · March 23, 2026

  Olympus Corporation of the Americas

  Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

  Potential for detachment of a distal tip component of the device during use.

  Class II

• Medical Device Recall · March 23, 2026

  Hologic, Inc

  Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes

  It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.

  Class II

• Medical Device Recall · March 23, 2026

  Olympus Corporation of the Americas

  Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

  Potential for detachment of a distal tip component of the device during use.

  Class II

• Medical Device Recall · March 23, 2026

  Olympus Corporation of the Americas

  Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

  Potential for detachment of a distal tip component of the device during use.

  Class II

• Medical Device Recall · March 20, 2026

  Foundation Medicine, Inc.

  Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

  Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

  Class II

• Medical Device Recall · March 20, 2026

  Centinel Spine, Inc.

  Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

  Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

  Class II

• Medical Device Recall · March 20, 2026

  Centinel Spine, Inc.

  Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

  Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Integra LifeSciences Corp. (NeuroSciences)

  Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

  Increased rate of out-of-specification endotoxin results.

  Class II

• Medical Device Recall · March 19, 2026

  B Braun Medical Inc

  B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

  Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

  Class I

• Medical Device Recall · March 19, 2026

  Integra LifeSciences Corp. (NeuroSciences)

  Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

  Increased rate of out-of-specification endotoxin results.

  Class II

• Medical Device Recall · March 19, 2026

  B Braun Medical Inc

  B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

  Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

  Class I

• Medical Device Recall · March 19, 2026

  B Braun Medical Inc

  B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

  Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

  Class I

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ00459

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  United Orthopedic Corp.

  Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument

  Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

  Class II

• Medical Device Recall · March 19, 2026

  B Braun Medical Inc

  B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

  Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

  Class I

• Medical Device Recall · March 19, 2026

  B Braun Medical Inc

  B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

  Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

  Class I

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS98

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Integra LifeSciences Corp. (NeuroSciences)

  Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

  Increased rate of out-of-specification endotoxin results.

  Class II

• Medical Device Recall · March 19, 2026

  DJO, LLC

  Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit h

  Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Nu

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Integra LifeSciences Corp. (NeuroSciences)

  Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

  Increased rate of out-of-specification endotoxin results.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  American Contract Systems Inc

  Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

  Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

  Class I

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3.

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYN

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Elekta, Inc.

  Brand Name: Leksell Vantage Arc System REF: 1053958

  Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  DJO, LLC

  Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold th

  Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. O

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  Medline Industries, LP

  Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B;

  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

  Class II

• Medical Device Recall · March 19, 2026

  United Orthopedic Corp.

  Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument

  Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

  Class II