Drugs & medical recalls in the United States
- 2026-10-14
USIntellijoint Surgical, Inc. recalls Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint…
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may…
FDA · DeviceIntellijoint Surgical, Inc.Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the…Official notice →- US
Steris Corporation recalls HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect…
FDA · DeviceSteris CorporationWorldwide - US Nationwide and the countries of Australia, Canada, New Zealand.Official notice → - US
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.Official notice → - US
Mindray DS USA, Inc. recalls ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- US
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice → - US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCWorldwide - US Nationwide distribution in the states and territory of AK, AR,…Official notice → - US
AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Product may be potentially contaminated with a lubricant used during the manufacturing process.
FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Official notice → - US
Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of North Carolina, and California.Official notice → - US
Nihon Kohden America LLC recalls Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions:…
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
FDA · DeviceNihon Kohden America LLCUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The…
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The…
FDA · DeviceMedtronic MiniMed, Inc.U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI,…Official notice → - US
Medline Industries, LP recalls Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide…
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach…
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma…
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the state of NJ.Official notice → - US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
- US
Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521…
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
- US
DRG International, Inc. recalls Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Potential for false negative patient results.
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice → - US
Safeguard US Operating LLC recalls Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC;…
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
FDA · DeviceSafeguard US Operating LLCWorldwide - US Nationwide distribution including in the states of FL, OK, CA,…Official notice → - US
Limitless Cryo Spa LLC recalls Glypto Device, Glypto Cryo Machine;
Lack of 510(k) clearance.
- US
Cardinal Health 200, LLC recalls Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J…
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a…
- US
PHILIPS MEDICAL SYSTEMS recalls Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333…
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
FDA · DevicePHILIPS MEDICAL SYSTEMSWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL,…Official notice → - US
GRI Medical & Electronic Technology Co., Ltd. recalls HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
FDA · DeviceGRI Medical & Electronic Technology Co., Ltd.US Nationwide distribution in the state of MS.Official notice → - US
QUANTUM OPS Inc recalls Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis);…
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
FDA · DeviceQUANTUM OPS IncU.S. Nationwide distribution in the states of CA and TX.Official notice → - US
Steris Corporation recalls VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological…
- US
Medical Action Industries, Inc. 306 recalls Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number:…
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
- US
Centric Compounding LLC recalls Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr.…
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- US
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro…
Failed Impurities/Degradation Specifications
- US
Carolina Infusion, LLC recalls TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- US
Carolina Infusion, LLC recalls QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- US
- US
Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
Failed Impurities/Degradation Specifications
- US
- US
- US
- 2026-10-07
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
The potential for falsely elevated results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the…
FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN,…Official notice → - US
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…
Due to incorrect inside packaging label for eyepiece.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of AZ, CA and MO.Official notice → - US
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965…
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA,…Official notice → - US
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog…
Due to manufacturing issues reperfusion catheters may fracture.
FDA · DevicePenumbra Inc.US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX,…Official notice → - US
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version…
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous…
- US
Olympus Corporation of the Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE…
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the country of Poland.Official notice →