Medical Device Recalls
RSS ↗7,870 medical device recalls from federal enforcement feeds.
Showing 101–150 of 7,870
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see theDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKUDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199ADuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820BDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit NDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full lDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 4, 2026
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Class II
Medical Device Recall · May 1, 2026
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXXGE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Class II
Medical Device Recall · May 1, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
- Class II
Medical Device Recall · May 1, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Class II
Medical Device Recall · May 1, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Class II
Medical Device Recall · May 1, 2026
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsGE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Class II
Medical Device Recall · April 30, 2026
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
- Class II
Medical Device Recall · April 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinetFingerprint scanner may overheat to a temperature to cause 1st degree burn.
- Class II
Medical Device Recall · April 30, 2026
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: NoLidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: NoLidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
BD Pyxis Mini Main REF: 349 Medication cabinetFingerprint scanner may overheat to a temperature to cause 1st degree burn.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Halyard, Drape Pack. Kit Code: LMDP36-01.Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
- Class II
Medical Device Recall · April 30, 2026
BD Pyxis MedStation ES REF: 323 Medication cabinetFingerprint scanner may overheat to a temperature to cause 1st degree burn.
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: NoLidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Class II
Medical Device Recall · April 30, 2026
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic EaDue to incorrect shelf-life expiration date.