Recalls in 2025
By month
Drugs & medical recalls in the United States in 2025
- 2025-12-31
USBeckman Coulter Ireland, Inc. recalls BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative…
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
FDA · DeviceBeckman Coulter Ireland, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →- US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN…
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice → - US
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3)…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not…
- US
Diasol, Inc recalls Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
FDA · DeviceDiasol, IncUS Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Official notice → - US
Microbiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- US
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue…
FDA · DeviceZimmer, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO,…Official notice → - US
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they…
FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA,…Official notice → - US
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do…
FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC,…Official notice → - US
Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR)…
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis…
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of CO, IN, OH,…Official notice → - US
Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04,…
Ophthalmic procedure packs may have incomplete seals affecting sterility.
FDA · DeviceAlcon Research LLCUS Nationwide distribution in the states of CA, ND, UT.Official notice → - US
Draeger, Inc. recalls Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS,…Official notice → - US
AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
- US
Merck Sharp & Dohme LLC recalls Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ…
Presence of particulate matter: potential presence of metal particulates in the product.
- 2025-12-24
- US
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series…
FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - US
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice → - US
Medtronic MiniMed, Inc. recalls InPen App, Model/CFN Number: MMT-8061 (Android Users)
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on…
FDA · DeviceMedtronic MiniMed, Inc.US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…Official notice → - US
Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
FDA · DeviceSmith & Nephew, Inc.US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN,…Official notice → - US
Myofunctional Research Company USA recalls Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3…
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
FDA · DeviceMyofunctional Research Company USAU.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL,…Official notice → - US
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
FDA · DeviceRocket Medical PlcDomestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE,…Official notice → - US
DSAART LLC recalls Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code:…
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
FDA · DeviceDSAART LLCU.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY,…Official notice → - US
Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
FDA · DeviceCopan ItaliaUS Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN,…Official notice → - US
Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP…
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
FDA · DeviceCopan ItaliaUS Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN,…Official notice → - US
DICOM Grid, Inc. recalls Intelerad InteleShare software, with ProViewer component
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction…
FDA · DeviceDICOM Grid, Inc.US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ,…Official notice → - US
PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can…
- US
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
FDA · DeviceInstrumentation LaboratoryDomestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL,…Official notice → - US
SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation…
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However,…
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ,…Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
- US
GE Healthcare GmbH recalls GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
- US
Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
FDA · DeviceDatascope Corp.Domestic: Nationwide distribution. International: Albania, Algeria, Angola,…Official notice → - US
AVID Medical, Inc. recalls Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Potential for incomplete seal on header bag.
- US
Zimmer Surgical Inc recalls Zimmer Air Dermatome, Model/Catalog Number: 00880100100
The devices may have a misaligned thickness control bar.
FDA · DeviceZimmer Surgical IncDistribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia,…Official notice → - US
Medline Industries, LP recalls SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states CA, CO, IL, KS, and MI.Official notice → - US
Mindray DS USA, Inc. dba Mindray North America recalls Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed…
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia…
FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA · DeviceFresenius Kabi USA, LLCUS (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ,…Official notice → - US
SUN PHARMA /TARO recalls Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY…
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- US
Preferred Pharmaceuticals, Inc. recalls Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred…
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished…
- US
SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for:…
Subpotent product:out of specification assay results observed during long term stability testing.