Injection needles recalled due to cleaning efficacy concerns
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.
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 a Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—inability to assure cleaning efficacy—but presents a potential infection risk in surgical use, meeting the criterion for a risk-of-harm product without reported injury.
Plain-English summary
Karl Storz Endoscopy is recalling six models of injection needles intended for general surgery and visceral surgery. The affected products have reference numbers 738750, 738752, 738756, 738758, 810505, and 810506, and include approximately 4,470 units.
The manufacturer initiated the recall because the efficacy of the manual cleaning process cannot be assured for these needles. If used without proper sterilization, these needles may expose patients to a higher risk of infection during surgical procedures.
The recalled needles were distributed throughout the United States in 34 states and Washington, D.C., as well as internationally in Mexico, Canada, and Germany.
Healthcare facilities that use these injection needles should verify their inventory against the affected reference numbers and contact Karl Storz Endoscopy for guidance on the recall.
The recalled product
- Product
- Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 4,470
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 (6)
- REF/UDI-DI: 738750/04048551195437
- 738752/04048551195444
- 738756/04048551195451
- 738758/04048551195468
- 810505/04048551203842
- 810506/04048551001660 All lot numbers.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Karl Storz Endoscopy 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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