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Philips Incisive CT scanners recalled for loose component riskPhilips is recalling two CT scanner models, the Incisive CT and CT 5300, covering 2,347 units. The tube heat exchanger screws may not be tightened properly after a replacement, so the part could detach and contact other components during scanner rotation, possibly damaging them. No injuries have been reported.
ModerateFDADec 10, 20252 products
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
FDADec 10, 2025
- Siemens MAMMOMAT operator tables recalled for bus installation risk
Siemens is recalling 14 units across three MAMMOMAT mammography systems: Revelation, Inspiration, and Fusion. Some operator tables were sold together with a bus-installation kit, but they are designed only for stationary use and are not released for bus installations. No injuries have been reported.
ModerateFDADec 10, 20253 products
- KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDADec 10, 2025Microbiologics
- Olympus OER-Elite, OER-Pro and OER-Mini recalled for missing safety information
Aizu Olympus is recalling three Olympus OER device models (OER-Elite, OER-Pro and OER-Mini). The recall is to inform customers about existing warnings and cautions, recommended maintenance schedules, and the need for only properly trained personnel to perform repairs and maintenance. No injuries have been reported.
ModerateFDADec 10, 2025Aizu Olympus3 products
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
FDADec 10, 2025
- Philips IntelliVue patient monitors recalled for failure-to-alarm issue
Philips is recalling 22 IntelliVue patient monitor models, including MP and MX series devices, because they may not sound an alarm when they should. The recall covers products distributed in the US and many other countries. No injuries have been reported.
ModerateFDADec 10, 202522 products
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDADec 10, 2025
- Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
FDADec 10, 2025
- Get Tested home test kits recalled for lacking FDA clearance
Get Tested is recalling 92 test products sold across the US because they were distributed without FDA premarket approval or clearance. The recall covers tests for conditions including pregnancy, sexually transmitted infections, diabetes, and Lyme disease. No injuries have been reported.
ModerateFDADec 10, 2025Get Tested92 products
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
FDADec 10, 2025
- InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
FDADec 10, 2025Enterix
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
FDADec 10, 2025
My Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules containing brown powderProduct may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
FDADec 10, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDADec 10, 20252 products
- Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
FDADec 10, 2025
- Dynashield, Nivagen, Globe and more recalled for quality issues
Blossom Pharmaceuticals is recalling 13 skin care and wound products over manufacturing quality problems, called cGMP deviations, that violate federal manufacturing rules. The products are sold under the Dynashield, Lanashield, Dynagel, WeCare, Nivagen and Globe names, and are distributed nationwide in the USA. No injuries have been reported.
ModerateFDADec 10, 2025Blossom Pharmaceuticals13 products
- Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
CGMP Deviations
FDADec 10, 2025Park Avenue Compounding
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
FDADec 10, 2025
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Defective Container - A defect in the side-seal which allows leakage of product.
FDADec 10, 2025
- Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Failed Stability Specifications: Observed OOS results: eg results for colour index
FDADec 10, 2025
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
FDADec 3, 2025
- IntelePACS - InteleConnect / TechPortal
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
FDADec 3, 2025Intelerad
- Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
FDADec 3, 2025
- Mindray V90 vaporizers recalled for anesthesia leakage
Mindray is recalling two models of V90 electronic vaporizers used with its A9 Anesthesia System, sevoflurane and isoflurane. The recall covers a potential for anesthesia leakage. No injuries have been reported, and no remedy has been specified by the FDA.
ModerateFDADec 3, 20252 products
- Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
FDADec 3, 2025
- B. Braun IV administration sets recalled for medication backflow risk
B. Braun is recalling 116 intravenous (IV) administration sets used with BBMI infusion pumps, including the Infusomat Space, Outlook, and Vista Basic. Medication can flow backward from secondary (piggyback) containers into primary containers, and some sets may not prime properly, which can block the flow. No injuries have been reported, and the products were distributed in the US, Canada, Germany, Guatemala, and Singapore.
ModerateFDADec 3, 2025116 products
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
FDADec 3, 2025BioFire Diagnostics
- NICO surgical products recalled for latex in packaging tape
Stryker is recalling three NICO product lines: Myriad handpieces, Myriad illumination packs, and BrainPath Shephard's hooks. The packaging tape used to secure components contains latex, even though the products are labeled latex-free. Latex can cause an allergic reaction in people who are sensitive to it. No injuries have been reported.
ModerateFDADec 3, 20253 products
- Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
FDADec 3, 2025Noah Medical