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.
Read the official notice →- Date
- 2025-01-29
- Country
- United States
- Brand
- Integra LifeSciences
- Product
- CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 →- 2025-02-19
US
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.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…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 →- 2024-10-16
US
Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube…
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC,…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-29
US
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
US
O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack…
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
FDA · DeviceO&M HALYARD, INC.US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS,…Official notice →US
Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of UK, Netherlands,…Official notice →US
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX), REF 343
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure,…
US
Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Lack of 510(k) clearance.
FDA · DeviceAdept Medical LtdUS Nationwide distribution. International: Canada, New Zealand, Australia,…Official notice →US
Percussionaire Corporation recalls VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk…
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
FDA · DevicePercussionaire CorporationWorldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO,…Official notice →