Medline Suction Catheters Recalled for Sterilization Error
Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.
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 medical device distributed without sterilization, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 120 units of MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12. The recall was initiated because the products were labeled as sterile but were distributed prior to the sterilization process.
The affected units, identified by Lot 28617070015, were distributed to facilities in Florida, Indiana, Tennessee, Georgia, New Jersey, Utah, Maryland, Nicaragua, and Honduras. The source text does not specify the exact dates of distribution or the specific facilities involved.
Consumers and healthcare providers should stop using these products immediately. Medline Industries Inc is the recalling firm responsible for this action.
The recalled product
- Product
- MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
- Manufacturer
- Medline Industries Inc
- Affected units
- 120
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)
- Lot 28617070015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries Inc 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 2 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighMedline Recalls ClearPro Closed Suction Catheters Due to Assembly Separation
FDA (Devices) · 2020-10-14
- SevereMedline Suction Catheter Kits Recalled for Potential Sterility Defects
FDA (Devices) · 2024-03-06
- HighMedline Recalls ClearPro T-Piece Closed Suction Catheters Due to Assembly Failure
FDA (Devices) · 2020-08-05
- SevereMedline Recalls ClearPro Trach T-Piece Closed Suction Catheters
FDA (Devices) · 2020-08-05
- HighMedline suction catheters recalled due to connector separation risk
FDA (Devices) · 2022-10-05
- SevereMedline Catheterization Kits Recalled for Potential Sterility Defect
FDA (Devices) · 2024-03-06