Medline Recalls Rigid Suction Canisters Due to Implosion Risk
Medline Industries is recalling 7,680 Rigid Suction Canisters (2000 CC and 3000 CC) because they may implode when subjected to excessive negative pressure.
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 risk-of-harm product (implosion) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Medline Industries Inc is recalling 7,680 units of Rigid Suction Canisters, specifically the 3000 CC and 2000 CC models. The affected products are identified by product codes OR220 and OR230 and lot numbers ranging from 9961601xxxx through 9961604xxxx.
The recall is being conducted because the canisters pose a risk of implosion if they are subjected to excessive negative pressure during use. This defect could potentially cause the rigid container to collapse inward.
The affected units were distributed in the United States to the following states: California, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, and Washington. Consumers and healthcare facilities should stop using these specific canisters and contact Medline Industries for further instructions.
The recalled product
- Product
- Rigid Suction Canister 3000 CC and 2000 CC.
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 7,680
Distribution
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
Similar recalls
- HighMedline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk
FDA (Devices) · 2019-10-30
- SevereMedline Recalls Semi-Rigid Suction Liners Due to Suction Loss
FDA (Devices) · 2024-09-18
- ModerateMedline soft suction canister liner dimensional variation causes difficult fitting
FDA (Devices) · 2024-08-28
- ModerateMedline Soft Suction Canister Liner Recalled for Dimensional Variation
FDA (Devices) · 2024-08-28
- HighMedline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction
FDA (Devices) · 2024-09-18
- ModerateMedline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging
FDA (Devices) · 2018-09-05