Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 451–500 of 8,553
- Class I
Medical Device Recall · June 11, 2026
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessoriesA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
Medical Device Recall · June 11, 2026
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessoriesA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class II
Medical Device Recall · June 11, 2026
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Class I
Medical Device Recall · June 10, 2026
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Class I
Medical Device Recall · June 10, 2026
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Class II
Medical Device Recall · June 10, 2026
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation deviceUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Class II
Medical Device Recall · June 10, 2026
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Class II
Medical Device Recall · June 10, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
- Class II
Medical Device Recall · June 10, 2026
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation deviceUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Class II
Medical Device Recall · June 10, 2026
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation deviceUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Class II
Medical Device Recall · June 10, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651JKits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
- Class II
Medical Device Recall · June 10, 2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Class II
Medical Device Recall · June 10, 2026
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation deviceUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Class II
Medical Device Recall · June 10, 2026
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.Software issue that can cause an increase in spontaneous software closures.
- Class I
Medical Device Recall · June 10, 2026
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Class II
Medical Device Recall · June 9, 2026
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description:Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- Class II
Medical Device Recall · June 9, 2026
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: DPotential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- Class II
Medical Device Recall · June 9, 2026
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius SurgicalSecure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
- Class II
Medical Device Recall · June 8, 2026
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392FAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
- Class II
Medical Device Recall · June 8, 2026
Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) SpineThe recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Class II
Medical Device Recall · June 8, 2026
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class II
Medical Device Recall · June 8, 2026
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class I
Medical Device Recall · June 8, 2026
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4)The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,A product error defect may cause incorrect bracket placement.
- Class I
Medical Device Recall · June 8, 2026
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556NThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822BAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class II
Medical Device Recall · June 8, 2026
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RSurgical dressing manufactured out of specification (greater thickness).
- Class II
Medical Device Recall · June 8, 2026
Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro SpThe recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Class II
Medical Device Recall · June 8, 2026
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116GAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susDue to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
- Class II
Medical Device Recall · June 8, 2026
Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116IAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverterIncorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Class II
Medical Device Recall · June 8, 2026
Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A;The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779UAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206JAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477MAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverterIncorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Class II
Medical Device Recall · June 8, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523MAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
- Class II
Medical Device Recall · June 8, 2026
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class I
Medical Device Recall · June 5, 2026
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640GMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
- Class II
Medical Device Recall · June 5, 2026
Optima XR200amx, Mobile Digital-Ready Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
- Class I
Medical Device Recall · June 5, 2026
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
- Class II
Medical Device Recall · June 5, 2026
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
- Class II
Medical Device Recall · June 5, 2026
Olympus Corporation of the Americas
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the inOlympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.