Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 1,951–2,000 of 8,689
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567AMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109DMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number:Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus enDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire forDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 6, 2026
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class II
Medical Device Recall · January 6, 2026
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate SystemThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class III
Medical Device Recall · January 6, 2026
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMThe mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- Class II
Medical Device Recall · January 5, 2026
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
- Class II
Medical Device Recall · January 5, 2026
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number:Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
- Class II
Medical Device Recall · January 5, 2026
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
- Class II
Medical Device Recall · January 5, 2026
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degr942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
- Class II
Medical Device Recall · January 5, 2026
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
- Class II
Medical Device Recall · January 5, 2026
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DDue to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
- Class II
Medical Device Recall · January 5, 2026
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
- Class II
Medical Device Recall · January 5, 2026
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
- Class II
Medical Device Recall · January 5, 2026
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARDPotential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
- Class II
Medical Device Recall · January 2, 2026
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.Tyvek bag seal issue which may compromise sterility of the kit.
- Class II
Medical Device Recall · January 2, 2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use inDue a design issue where the navigated array connection geometry is incorrect.
- Class II
Medical Device Recall · January 2, 2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use inDue a design issue where the navigated array connection geometry is incorrect.
- Class II
Medical Device Recall · December 31, 2025
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IUnder circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
- Class II
Medical Device Recall · December 31, 2025
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
- Class II
Medical Device Recall · December 31, 2025
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: NoProducts were mislabeled as the 6mm product but included the 5 mm product.
- Class II
Medical Device Recall · December 31, 2025
BEAR Implant. Model Number: 1000.Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
- Class II
Medical Device Recall · December 30, 2025
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
- Class I
Medical Device Recall · December 29, 2025
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.Cyber vulnerability of BLE communication was found by CISA VDP program.
- Class II
Medical Device Recall · December 29, 2025
Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- Class II
Medical Device Recall · December 29, 2025
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010Incorrect expiration date
- Class II
Medical Device Recall · December 29, 2025
Siemens Medical Solutions USA, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- Class I
Medical Device Recall · December 29, 2025
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.Cyber vulnerability of BLE communication was found by CISA VDP program.
- Class II
Medical Device Recall · December 26, 2025
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED COPotential exposure of rodents and rodent activity in the distribution center.
- Class II
Medical Device Recall · December 26, 2025
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVERPotential exposure of rodents and rodent activity in the distribution center.
- Class II
Medical Device Recall · December 26, 2025
PREGNANCY TEST 24CTPotential exposure of rodents and rodent activity in the distribution center.
- Class II
Medical Device Recall · December 26, 2025
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CTPotential exposure of rodents and rodent activity in the distribution center.
- Class II
Medical Device Recall · December 26, 2025
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.Potential exposure of rodents and rodent activity in the distribution center.
- Class II
Medical Device Recall · December 26, 2025
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 CardinaThe firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
- Class II
Medical Device Recall · December 24, 2025
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277AMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- Class II
Medical Device Recall · December 24, 2025
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387BMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- Class II
Medical Device Recall · December 24, 2025
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT1661Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- Class II
Medical Device Recall · December 24, 2025
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245BA smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
- Class II
Medical Device Recall · December 24, 2025
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980AMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- Class II
Medical Device Recall · December 24, 2025
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.