Medical Device Recalls

8,553 medical device recalls from federal enforcement feeds.

Showing 201–250 of 8,553

• Medical Device Recall · July 20, 2026

  GE Medical Systems Information Technologies Inc

  FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

  Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

  Class II

• Medical Device Recall · July 20, 2026

  Midmark Corporation

  Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

  A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

  Class II

• Medical Device Recall · July 17, 2026

  Remel Europe Ltd.

  Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

  Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

  Class II

• Medical Device Recall · July 16, 2026

  Biofire Defense

  FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended

  Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

  Class II

• Medical Device Recall · July 16, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar

  Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

  Class II

• Medical Device Recall · July 16, 2026

  Straumann USA LLC

  Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

  Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

  Class II

• Medical Device Recall · July 16, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

  Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

  Class II

• Medical Device Recall · July 15, 2026

  F & A Foundation

  Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/15

  Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

  Class II

• Medical Device Recall · July 15, 2026

  Beckman Coulter Inc.

  Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analy

  a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

  Class II

• Medical Device Recall · July 15, 2026

  Beckman Coulter Inc.

  Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C6352

  a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

  Class II

• Medical Device Recall · July 15, 2026

  BMC Medical Co., Ltd.

  BMC/REACTHEALTH Luna G3 APAP REF LG 3600

  Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

  Class I

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Fresenius Medical Care Renal Therapies Group, LLC

  NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for

  Complaints of blue-green discoloration in product

  Class II

• Medical Device Recall · July 14, 2026

  AVID Medical, Inc.

  Halyard IV Start Kit Non-Sterile REF: KRIV26-02

  Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Ca

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  AVID Medical, Inc.

  Halyard IV START KIT NON-STERILE REF: KRIV26-02

  Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

  Class I

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catal

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catal

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog N

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Boston Scientific Corporation

  OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

  Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

  Class II

• Medical Device Recall · July 14, 2026

  Hollister Ulc

  Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Inter

  Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  ConMed Corporation

  CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile

  Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Fresenius Medical Care Renal Therapies Group, LLC

  Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis

  Complaints of blue-green discoloration in product

  Class II

• Medical Device Recall · July 14, 2026

  Boston Scientific Corporation

  Suture Cinch Long 1pk. Endoscopic tissue approximation device.

  Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

  Class II

• Medical Device Recall · July 14, 2026

  Cardinal Health 200, LLC

  Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Cata

  Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

  Class II

• Medical Device Recall · July 14, 2026

  Fresenius Medical Care Renal Therapies Group, LLC

  GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

  Complaints of blue-green discoloration in product

  Class II

• Medical Device Recall · July 13, 2026

  Medtronic MiniMed, Inc.

  MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

  Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

  Class II

• Medical Device Recall · July 13, 2026

  OBP Medical Corporation

  OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

  There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

  Class II

• Medical Device Recall · July 13, 2026

  Siemens Healthcare Diagnostics, Inc.

  Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

  Class II

• Medical Device Recall · July 13, 2026

  Medline Industries, LP

  Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONAT

  Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

  Class II

• Medical Device Recall · July 13, 2026

  Medline Industries, LP

  Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSO

  Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

  Class II

• Medical Device Recall · July 13, 2026

  Siemens Healthcare Diagnostics Products Ltd.

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

  Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

  Class II

• Medical Device Recall · July 13, 2026

  Gentherm Medical, LLC

  Blanketrol III, Model 233; Thermal regulating system.

  Overheating of the 115V CPU board may cause the device to shut down.

  Class II

• Medical Device Recall · July 13, 2026

  Straumann USA LLC

  GM Helix Implant, Endosseous Dental Implant Article No. 109.984

  There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

  Class II

• Medical Device Recall · July 13, 2026

  Medtronic MiniMed, Inc.

  MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

  Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

  Class II

• Medical Device Recall · July 13, 2026

  Gentherm Medical, LLC

  Innercool Coolblue Console, Model STx; Thermal regulating system.

  Overheating of the 115V CPU board may cause the device to shut down.

  Class II

• Medical Device Recall · July 13, 2026

  Medtronic MiniMed, Inc.

  MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

  Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

  Class II

• Medical Device Recall · July 13, 2026

  Siemens Healthcare Diagnostics, Inc.

  Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

  Class II

• Medical Device Recall · July 13, 2026

  Siemens Healthcare Diagnostics Products Ltd.

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

  Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

  Class II

• Medical Device Recall · July 13, 2026

  Gentherm Medical, LLC

  Blanketrol II Model 222S; Thermal regulating system.

  Overheating of the 115V CPU board may cause the device to shut down.

  Class II

• Medical Device Recall · July 13, 2026

  Kico Knee Innovation Company

  Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARV

  Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

  Class II

• Medical Device Recall · July 13, 2026

  Medline Industries, LP

  Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.

  Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

  Class II

• Medical Device Recall · July 10, 2026

  Medline Industries, LP

  Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330

  Component labeling discrepancy

  Class II

• Medical Device Recall · July 10, 2026

  Paragon 28, Inc.

  Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

  Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

  Class III

• Medical Device Recall · July 10, 2026

  Medline Industries, LP

  Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.

  Kits contain a potentially contaminated component which were recalled by the manufacturer

  Class II

• Medical Device Recall · July 10, 2026

  Medline Industries, LP

  Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG

  Kits contain a potentially contaminated component which were recalled by the manufacturer

  Class II

• Medical Device Recall · July 10, 2026

  Medline Industries, LP

  Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT

  Kits contain a potentially contaminated component which were recalled by the manufacturer

  Class II

• Medical Device Recall · July 10, 2026

  Medline Industries, LP

  Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B

  Kits contain a potentially contaminated component which were recalled by the manufacturer

  Class II