Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 1,651–1,700 of 8,689
- Class I
Medical Device Recall · February 13, 2026
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H7816F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
- Class II
Medical Device Recall · February 13, 2026
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class II
Medical Device Recall · February 13, 2026
MiniMed 530G Insulin Pump (MMT-551, MMT-751)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class II
Medical Device Recall · February 13, 2026
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class II
Medical Device Recall · February 13, 2026
MiniMed 620G Insulin Pump (MMT-1750)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Class I
Medical Device Recall · February 13, 2026
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
- Class II
Medical Device Recall · February 12, 2026
Olympus Corporation of the Americas
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Class II
Medical Device Recall · February 12, 2026
Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Class I
Medical Device Recall · February 12, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useProbes may rupture/burst during activation
- Class II
Medical Device Recall · February 12, 2026
Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Class I
Medical Device Recall · February 12, 2026
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical useProbes may rupture/burst during activation
- Class I
Medical Device Recall · February 12, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useProbes may rupture/burst during activation
- Class II
Medical Device Recall · February 12, 2026
Olympus Corporation of the Americas
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Class II
Medical Device Recall · February 11, 2026
TMJ Bilateral Implants, REF: CHG020Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Wrap Aprons.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Caps.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Kilt Blockers.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Protective Sleeves.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, VestPotential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Half Aprons.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Blockers.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Thyroid Shield.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
BD Alaris" System with Guardrails" Suite MX with Point of Care UnitDue to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, KiltPotential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Demi Half Aprons.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Leg Wraps.Potential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 11, 2026
Burlington Medical, Frontal ApronsPotential for attenuation degradation over time, decreasing the lifespan.
- Class II
Medical Device Recall · February 10, 2026
Artegraft Vascular Graft; REF#: AG740;Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Class II
Medical Device Recall · February 10, 2026
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
- Class II
Medical Device Recall · February 10, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemDrill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Class II
Medical Device Recall · February 10, 2026
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
- Class II
Medical Device Recall · February 10, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemDrill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Class II
Medical Device Recall · February 9, 2026
Abbott Diagnostics Scarborough, Inc.
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique ComponIt was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Class II
Medical Device Recall · February 9, 2026
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
- Class III
Medical Device Recall · February 6, 2026
Battery Charging Station; Model: 0998-00-0802;The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01,The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 6, 2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRSoftware anomaly in the patient positioning system may result in positional discrepancy.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 6, 2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRSoftware anomaly in the patient positioning system may result in positional discrepancy.
- Class II
Medical Device Recall · February 6, 2026
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)Augmentation devices failed bacterial endotoxin testing.
- Class II
Medical Device Recall · February 6, 2026
BD Kiestra" ReadA; Catalog No.: 446948.In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/REThe system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 6, 2026
Artelon FlexBand Plus Ref: 41054 & 41057Augmentation devices failed bacterial endotoxin testing.
- Class II
Medical Device Recall · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057Augmentation devices failed bacterial endotoxin testing.
- Class I
Medical Device Recall · February 6, 2026
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REThe system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
- Class II
Medical Device Recall · February 5, 2026
Campy CVA Medium 100/PK, R01272Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- Class II
Medical Device Recall · February 5, 2026
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative detAfter receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.