Recalls in 2024
By month
Most recalled brands
Drugs & medical recalls in the United States in 2024
- 2024-12-25
USMint Medical GmbH recalls mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
FDA · DeviceMint Medical GmbHWorldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA,…Official notice →- US
Olympus Corporation of the Americas recalls Duravent Silicone Ventilation Tube. Model Number: 240075.
Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
FDA · DeviceOlympus Corporation of the AmericasAL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI.…Official notice → - US
GE OEC Medical Systems, Inc recalls OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to…
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
FDA · DeviceGE OEC Medical Systems, IncU.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - US
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2)…
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
- US
MicroPort Orthopedics Inc. recalls EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE…
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending…
- US
Noah Medical recalls Galaxy System (GAL-001)
Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is…
FDA · DeviceNoah MedicalUS: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NYOfficial notice → - US
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An…
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
FDA · DeviceCooperSurgical, Inc.States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below,…Official notice → - US
Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to…
- US
Spacelabs Healthcare, Ltd. recalls Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory…
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the…
FDA · DeviceSpacelabs Healthcare, Ltd.U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA,…Official notice → - US
Spectranetics Corporation recalls Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 /…
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
FDA · DeviceSpectranetics CorporationU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY,…Official notice → - US
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in…
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.No Atlan A300 or A300XL devices were imported into the US. Devices were direct…Official notice → - US
Medtronic Neurosurgery recalls Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666…
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
FDA · DeviceMedtronic NeurosurgeryWorldwide distribution. US nationwide including Puerto Rico; Algeria,…Official notice → - US
Kirwan Surgical Products, LLC recalls Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical…
Potential for the outer stainless-steel tube to break or detach.
FDA · DeviceKirwan Surgical Products, LLCWorldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE,…Official notice → - US
Macleods Pharmaceuticals Ltd recalls Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540,…
Failed Impurities/Degradation Specifications
- US
- US
Apothecus Pharmaceutical Corp. recalls VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus…
CGMP deviations: out of specifications for assay
FDA · DrugApothecus Pharmaceutical Corp.Nationwide in the USA and 2 Distributors in Hong KongOfficial notice → - US
- US
Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
- US
Keystone Industries recalls Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd.,…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was…
FDA · DrugKeystone IndustriesNationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras,…Official notice → - 2024-12-18
- US
Noah Medical recalls Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive…
FDA · DeviceNoah MedicalUS Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ,…Official notice → - US
Hermes Medical Solutions AB recalls Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
FDA · DeviceHermes Medical Solutions ABU.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.:…Official notice → - US
Diasorin Inc. recalls DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose…
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura…
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice → - US
Cardinal Health 200, LLC recalls Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL,…
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level…
- US
Beckman Coulter Inc. recalls Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact…
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid…
FDA · DeviceBeckman Coulter Inc.Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of OK, LA, FL,…Official notice → - US
Hologic, Inc recalls Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- US
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV19
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a…
- US
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
- US
Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- US
Microline Surgical, Inc. recalls Microscissor Tip (Disposable); Microline Catalog #: 3122.
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
FDA · DeviceMicroline Surgical, Inc.Worldwide - US Nationwide in the state of OK and the country of Japan.Official notice → - US
ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The…
Due to finished goods incorrectly packaged and labeled.
FDA · DeviceICU Medical, Inc.Worldwide - U.S. Nationwide distribution in the state of IL and the country of…Official notice → - US
Folsom Metal Products, Inc. recalls DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1.…
Units were not intended for commercial distribution and inadvertently distributed.
- US
- US
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend…
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- US
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC…
Superpotent Drug and Subpotent Drug: potency failures obtained
- US
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…
Failed Impurities/Degradation Specifications
- US
- US
LNK International, Inc. recalls Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg,…
CGMP Deviations: Released product should have been rejected.
FDA · DrugLNK International, Inc.Product was distributed to 1 wholesale retail customer who may have further…Official notice →