Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 51–100 of 8,553
- Class I
Medical Device Recall · August 11, 2026
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
- Class II
Medical Device Recall · August 11, 2026
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Class I
Medical Device Recall · August 11, 2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
- Class I
Medical Device Recall · August 11, 2026
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A;The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
- Class II
Medical Device Recall · August 11, 2026
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Class I
Medical Device Recall · August 11, 2026
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187AThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
- Class II
Medical Device Recall · August 10, 2026
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Class I
Medical Device Recall · August 10, 2026
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Class II
Medical Device Recall · August 10, 2026
Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Class II
Medical Device Recall · August 10, 2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
- Class II
Medical Device Recall · August 10, 2026
Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3CHeightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Class II
Medical Device Recall · August 10, 2026
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , CataloThe kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
- Class II
Medical Device Recall · August 10, 2026
Fresenius Medical Care Renal Therapies Group, LLC
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Class I
Medical Device Recall · August 10, 2026
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Class II
Medical Device Recall · August 10, 2026
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R;The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Class II
Medical Device Recall · August 10, 2026
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Class I
Medical Device Recall · August 10, 2026
Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Class II
Medical Device Recall · August 10, 2026
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325AThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Class II
Medical Device Recall · August 10, 2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
- Class I
Medical Device Recall · August 10, 2026
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Shthis is a downstream recall of class I recall RES 98777
- Class I
Medical Device Recall · August 10, 2026
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REFthis is a downstream recall of class I recall RES 98777
- Class II
Medical Device Recall · August 10, 2026
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , CatalogThe kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
- Class II
Medical Device Recall · August 10, 2026
Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Class II
Medical Device Recall · August 10, 2026
Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Class I
Medical Device Recall · August 10, 2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Class II
Medical Device Recall · August 7, 2026
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Class II
Medical Device Recall · August 7, 2026
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
- Class II
Medical Device Recall · August 7, 2026
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.xPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Class II
Medical Device Recall · August 7, 2026
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.xPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Class II
Medical Device Recall · August 7, 2026
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Class II
Medical Device Recall · August 7, 2026
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Class II
Medical Device Recall · August 7, 2026
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Class II
Medical Device Recall · August 7, 2026
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Class II
Medical Device Recall · August 7, 2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Class II
Medical Device Recall · August 7, 2026
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.xPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Class II
Medical Device Recall · August 7, 2026
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
- Class II
Medical Device Recall · August 6, 2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- Class I
Medical Device Recall · August 6, 2026
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
- Class II
Medical Device Recall · August 6, 2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Class II
Medical Device Recall · August 6, 2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segmentWheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.
- Class II
Medical Device Recall · August 6, 2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- Class II
Medical Device Recall · August 6, 2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Class II
Medical Device Recall · August 6, 2026
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Class II
Medical Device Recall · August 6, 2026
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The systUtilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
- Class II
Medical Device Recall · August 5, 2026
Nipro Renal Soultions USA, Corporation
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Hemodialysis concentrates contain high endotoxin levels
- Class II
Medical Device Recall · August 5, 2026
Nipro Renal Soultions USA, Corporation
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Hemodialysis concentrates contain high endotoxin levels
- Class II
Medical Device Recall · August 5, 2026
Nipro Renal Soultions USA, Corporation
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Hemodialysis concentrates contain high endotoxin levels
- Class II
Medical Device Recall · August 5, 2026
Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Hemodialysis concentrates contain high endotoxin levels
- Class II
Medical Device Recall · August 4, 2026
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
- Class II
Medical Device Recall · August 4, 2026
Canon Medical System, USA, INC.
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicatDue to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.