Recall center
Medicine and medical device recalls
Drug and medical device recalls from FDA enforcement reports. Newest first. Tap any recall for the full agency details and what to do.
Last 90 days (60)
- FDATonight We Ride, LLC: Male Supplement
Product contains undeclared Sildenafil, Tadalafil, and Dapoxetine
- FDAHouston Rx LLC: Sermorelin recall
Lack of process control
- FDATeva Pharmaceuticals USA, Inc: Metoclopramide Tablets recall
Presence of Foreign Tablets/Capsules
- FDAAmerican Health Packaging: Metoclopramide Tablets recall
Presence of Foreign Tablets/Capsules
- FDAZydus Pharmaceuticals (USA) Inc: Hydrocortisone Sodium Succinate for Injection recall
Failed Impurities/Degradation Specifications.
- FDAHouston Rx LLC: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL recall
Lack of assurance of sterility.
- FDAHowmedica Osteonics Corp.: TS Universal Baseplate Finishing Tray recall
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- FDAFerno-Washington Inc: Power F2 Powered Fastening System recall
Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.
- FDAHowmedica Osteonics Corp.: Triathlon Hinge Femoral Prep Tray recall
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAInstrumentation Laboratory: HemoslL AcuStar HIT-lgG(PF-4) recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- FDACook Incorporated: Williams Cystoscopic Injection Needles recall
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
- FDAMedtronic Sofamor Danek USA Inc: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with a recall
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.
- FDAMedline Industries, LP: Medline convenience kit labeled as: FOOT ANKLE recall
Discrepancy in the shelf-life of a component
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A C recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: OPEN HEART recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: VEIN HARVESTING PACK recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMagellan Diagnostics, Inc.: LeadCare II Blood Lead Test Kit recall
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
- FDABaxter Healthcare Corporation: Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Co recall
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
- FDABeckman Coulter, Inc.: DxU 840m Iris recall
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ9 recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) OPEN HEART CDS recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedtronic Sofamor Danek USA Inc: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with a recall
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection
- FDABioFire Diagnostics, LLC: Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection ( recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- FDAInstrumentation Laboratory: HemoslL AcuStar HIT-lgG(PF-4) recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- FDAINTELERAD MEDICAL SYSTEMS INCORPORATED: IntelePACS recall
Following a Chromium-based web-browser, report and displayed images may not match.
- FDAHowmedica Osteonics Corp.: TS Femoral Prep Tray recall
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKM recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDARadiometer Medical ApS: The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists recall
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
- FDACadwell Industries Inc: Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI recall
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.
- FDASI-BONE, Inc.: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm) recall
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- FDAIn2bones USA, LLC: REF: P65 ST862 CoLag SCREW recall
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) SPINAL CDS recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDABeckman Coulter, Inc.: IQ200 SPRINT recall
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.
- FDAJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter recall
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- FDASteris Corporation: RAPICIDE PA Part A High-Level Disinfectant recall
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- FDAMicrogenics Corporation: MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control recall
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
- FDAW L Gore & Associates, Inc.: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis recall
The potential for the devices to be mislabeled with the incorrect length.
- FDAJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter recall
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- FDAEthicon, LLC: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture recall
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDASteris Corporation: RAPICIDE PA Part A High-Level Disinfectant recall
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
- FDAINTEGRATED MEDCRAFT LLC: FORWARD Gunshot Wound Kit recall
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
- FDABioFire Diagnostics, LLC: Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plu recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- FDAMedline Industries, LP: 1) Product Name AUD OPEN HEART PACK recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP C recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDASarnova HC, Llc: Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk) recall
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYN recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDABecton Dickinson & Co.: BD Phoenix Panel NMIC-312 recall
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- FDAHealthmark Industries Co., Inc.: Vinyl Instrument Guards recall
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
- FDAMerit Medical Systems, Inc.: Scout MD recall
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
- FDAMedline Industries, LP: Medline surgical convenience kits labeled as: CABG AUXILIARY PACK recall
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- FDAMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LA recall
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
- FDAJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter recall
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
- FDABecton Dickinson & Co.: BD Phoenix Panel NMIC-306 recall
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- FDAHowmedica Osteonics Corp.: TS Misc recall
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- FDABioFire Diagnostics, LLC: Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Ca recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Earlier this year
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall
Lack of Assurance of Sterility
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0 recall
Lack of Assurance of Sterility
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDASupernus Pharmaceuticals, Inc.: Trokendi XR recall
Failed Dissolution Specifications
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAFresenius Kabi USA, LLC: Naropin (ropivacaine hydrochloride Injection recall
Presence of Particulate Matter: Hair was found in products
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Digi Eye (hypromellose 0 recall
Lack of Assurance of Sterility
- FDAFresenius Kabi USA, LLC: Xylocaine (lidocaine HCl Injection recall
Presence of Particulate Matter: Hair was found in products
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Dry Aid (povidone 0 recall
Lack of Assurance of Sterility
- FDAAscend Laboratories, LLC: Dabigatran etexilate Capsules recall
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAFresenius Kabi USA, LLC: Lidocaine HCl Injection recall
Presence of Particulate Matter: Hair was found in products
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall
Lack of Assurance of Sterility
- FDABionpharma Inc.: Divalproex Sodium Delayed-Release Tablets recall
Presence of Foreign Tablets/Capsules
- FDAAsclemed USA Inc.: Lidolog Kit recall
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
- FDAAscend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets recall
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0 recall
Lack of Assurance of Sterility
- FDAFresenius Kabi USA, LLC: Xylocaine (lidocaine HCl Injection recall
Presence of Particulate Matter: Hair was found in products
- FDAFresenius Kabi USA, LLC: Glycopyrrolate Injection recall
Presence of Particulate Matter: Hair was found in product
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDAPrecision Dose Inc.: Glycopyrrolate Oral Solution recall
Failed Impurities/Degradation Specifications
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDARising Pharma Holding, Inc.: Rising recall
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
- FDAJB Chemicals and Pharmaceuticals Ltd: Cetirizine Hydrochloride Tablets USP 5 mg recall
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
- FDAAscend Laboratories, LLC: Dabigatran etexilate Capsules recall
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0 recall
Lack of Assurance of Sterility
- FDAMajor Pharmaceuticals: Levothyroxine Sodium Tablets recall
Subpotent Drug
- FDARohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Dry Aid (povidone 0 recall
Lack of Assurance of Sterility
- FDABoston Scientific Corporation: FARADRIVE STEERABLE SHEATH CLEAR recall
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- FDABoston Scientific Corporation: FARASTAR Ablation Generator EU recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- FDAAVID Medical, Inc.: Halyard STANDARD LINE INSERTION PACK recall
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
- FDAPenumbra, Inc.: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall
Due to manufacturing issues, reperfusion catheters may fractures
- FDAAlphatec Spine, Inc.: SafeOp Patient Interface recall
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
- FDAMedtronic MiniMed, Inc.: MiniMed Go App recall
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.