Centurion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns
Centurion Medical Products is recalling 45 post-operative ophthalmic dressing kits because the eye pads inside may have had a breach in sterile packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach in sterile packaging for a medical device, which poses a risk of infection or harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling 45 Post-Operative Ophthalmic Dressing Kits. These kits contain individually packaged and sterilized Covidien Curity Oval Eye Pads, which are placed into non-sterile Centurion Convenience Kits along with other components. The recall is being conducted due to a supplier's recall regarding a potential breach in the sterile packaging of the eye pads.
The affected products were placed into the kits between July 2013 and January 2017. The specific batch numbers and expiration dates involved are 2016020950 (exp. 4/30/18), 201502650 (exp. 1/31/18), and 2014082550 (exp. 6/30/17). The products were distributed in New York, North Carolina, Pennsylvania, California, Ohio, Washington, Virginia, New Jersey, and Illinois.
Healthcare facilities and consumers should stop using these specific kits and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Centurion component code 2841
Distribution
Part of a larger recall action
This product is one of 7 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- SevereRecall of Sterile Eye Pads Due to Compromised Sterility Barrier
FDA (Devices) · 2017-04-12
- HighCenturion Universal Line Full Body Drape Kit Recalled for Packaging Defect
FDA (Devices) · 2019-11-13
- ModerateCenturion Medical Products Recalls Catheter Securement System Convenience Kits
FDA (Devices) · 2018-03-28
- HighMedline Centurion Medical Procedure Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighWindstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise
FDA (Devices) · 2017-04-19
- HighWindstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging
FDA (Devices) · 2017-04-19