Surgical instrument trays recalled for potential flaking metal and brown spots
Medical Action Industries recalls General Purpose Instrument Trays due to potential flaking metal and brown spots on hemostats. These defects could contaminate surgical instruments.
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: This is an FDA Class II recall of surgical instruments with a potential for metal contamination. No injuries or illnesses have been reported, but the hazard poses a theoretical risk of contamination during surgical procedures, meeting the criteria for high-severity rating.
Plain-English summary
Medical Action Industries, Inc. is recalling its General Purpose Instrument Trays (REF 61209) due to a potential defect involving flaking metal and/or brown spots on hemostats included in these trays.
The recalled product was distributed nationwide across 16 states including Ohio, Colorado, California, Illinois, Florida, Virginia, Texas, Minnesota, Georgia, Washington, Massachusetts, Maryland, New York, Louisiana, Arizona, and Oregon. Approximately 102 cases containing 20 units each were affected, identified by batch numbers 0000277610 and 0000276879, both with expiration dates of April 15, 2022.
Flaking metal or brown spots on surgical hemostats could introduce contamination into the surgical field. This is an FDA Class II recall.
The recalled product
- Product
- Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
- Manufacturer
- Medical Action Industries, Inc. 306
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 (3)
- Batch Numbers: 0000277610
- Exp. 04/15/2022
- 0000276879
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medical Action Industries, Inc. 306 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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