FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise
The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.
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 (medical device) where sterility is compromised, 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
The U.S. Food and Drug Administration (FDA) is recalling non-sterile Hysto Packs manufactured by Covidien LLC. The recall is due to a defect where the products contain splits or holes that compromise the sterility of the items.
The affected products include part numbers SA2059B (Major Basin), SA2220 (Hysto Pack), and SA2220A (Hysto Pack). The recall covers 23,560 units. The distribution pattern is worldwide, including the United States (nationwide, including the Virgin Islands), Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Netherlands, Sweden, Ireland, Israel, Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and the UAE.
The source text identifies the hazard as splits or holes compromising sterility. Consumers and healthcare providers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
- Manufacturer
- Covidien LLC
- Affected units
- 23,560
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 number begins 508xxxx or lower
Distribution
Part of a larger recall action
This product is one of 14 recalled by Covidien LLC 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.
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