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Page 39 of 40Severity
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: NoPrinter Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
FDANov 5, 2025Medistim
- Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
FDANov 5, 2025
- Daye tampons recalled for lacking FDA 510(k) clearance
Daye is recalling 29 tampon products, including bundles and refill packs, because they do not have the FDA 510(k) clearance required for this type of device. The recall was classified as Class II and covers products distributed nationwide. No injuries have been reported.
ModerateFDANov 5, 2025Daye29 products
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDANov 5, 2025
- Philips Incisive and CT 5300 scanners recalled for software faults
Philips is recalling three CT scanner models, Incisive CT, CT 5300, and Incisive CT for Brazil SKD, running software versions 5.1.0.X or 5.1.1.X. The software can cause patient positioning errors, missing or distorted images, and failed clinical scan triggers, which may lead to repeat scans. No injuries have been reported.
ModerateFDANov 5, 20253 products
- SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection,
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
FDANov 5, 2025Anatomy Supply Partners
- BD Pyxis medication systems recalled for fire risk
BD is recalling five Pyxis medication dispensing product lines because liquid can get inside the anesthesia or medication station. This may cause smoke, system downtime, or fire. No injuries have been reported.
ModerateFDANov 5, 20255 products
- Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
FDANov 5, 2025
- ICU Medical ChemoLock devices recalled for port leak risk
ICU Medical is recalling 38 ChemoLock drug transfer devices, including spikes, ports, and administration sets. The port weld can separate or break during use, which could cause a leak. No injuries have been reported.
ModerateFDANov 5, 202538 products
- VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
FDANov 5, 2025
- Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Potential for a weak seal in some units resulting in compromise in sterility.
FDANov 5, 2025
- Surgical Theater surgical planning software recalled for image misalignment risk
Surgical Theater is recalling seven surgical planning and navigation software products, 151 units in total. A software problem can misalign secondary image layers with the primary image when large rotational alignment values are used in 2D Image Fusion. No injuries have been reported.
ModerateFDANov 5, 2025Surgical Theater7 products
- Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
FDANov 5, 2025
- Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Potential for contamination with cotton fibers.
FDANov 5, 2025Endomagnetics2 products
- Aesculap trocar sealing components recalled for silicone fragment risk
Aesculap is recalling four surgical trocar sealing products because silicone fragments may detach from the yellow sealing component. The recall covers 347 units in total. No injuries have been reported.
ModerateFDANov 5, 2025Aesculap4 products
- Alcon surgical accessories recalled for incomplete sterile seals
Alcon is recalling five accessory devices used with Unity and Constellation surgical consoles. The pouches that keep the devices sterile may have incomplete seals. No injuries have been reported.
ModerateFDANov 5, 20255 products
- Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophil
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
FDANov 5, 2025Balt
- IMRIS Operating Suite MRI systems recalled for helium leak risk
Impris Imaging is recalling four IMRIS Operating Suite systems that include Siemens 3 Tesla MRI magnets. An ice blockage in the magnet venting system could keep helium from escaping during a quench, which could build pressure and rupture the helium containment system, possibly leaking helium into the scanning room. No injuries have been reported.
SeriousFDANov 5, 2025Impris Imaging4 products
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
FDANov 5, 20257 products
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lack of Assurance of Sterility: Potential for flexible container leaks.
FDANov 5, 2025
- Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
FDANov 5, 2025Endo USA4 products
- Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Labeling: Not Elsewhere Classified
FDANov 5, 2025Letco Medical
- Farmakeio testosterone pellets recalled for possible metal particles
Farmakeio Outsourcing is recalling 15 sterile testosterone pellets for under-the-skin insertion, including testosterone alone and testosterone combined with triamcinolone acetonide. The recall was filed because of manufacturing quality problems that could allow metal particles into the pellets. The products were distributed nationwide in the U.S. and in Antigua, and no injuries have been reported.
ModerateFDANov 5, 2025Farmakeio Outsourcing15 products
- ProRx semaglutide and tirzepatide vials recalled for sterility risk
ProRx is recalling seven multidose vials of semaglutide and tirzepatide injection, about 38,853 vials in total, distributed in Texas and Utah. The company cannot assure that the vials are sterile, so they could contain germs. No injuries have been reported.
ModerateFDANov 5, 2025ProRx7 products
- R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
Presence of Particulate Matter
FDANov 5, 2025QuVa Pharma
- Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDANov 5, 2025Heritage Pharmaceuticals6 products
- Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
FDANov 5, 20253 products
- Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
FDANov 5, 20253 products