Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A…
Potential that the induction seal is not completely sealed to the device tube packaging.
Read the official notice →- Date
- 2025-02-19
- Country
- United States
- Brand
- Integra LifeSciences
- Product
- Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Integra LifeSciences recalls
- 2025-05-14
USIntegra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of TX, MT, AL & OK.Official notice →- US
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - 2025-03-12
- US
Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers…
Possibility for the obturator to break (separate).
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA,…Official notice → - 2025-01-29
- US
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA,…Official notice → - 2024-11-06
- US
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Out of specification endotoxin levels.
- US
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great…Official notice →
Other drugs & medical recalls in the United States
- 2025-02-26
- US
- 2025-02-19
- US
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- US
Murata Vios, Inc. recalls Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be…
- US
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
FDA · DeviceExactech, Inc.U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK,…Official notice → - US
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration…
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Netherlands,…Official notice → - US
Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
FDA · DeviceElekta, Inc.US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina…Official notice →