Fetzer Medical Recalls Obstetrical Forceps Due to Functional Defect
Fetzer Medical is recalling 174 units of Luikart Simpson OB Forceps because doctors reported being unable to pull the instruments apart.
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 with a functional defect that could impede its use during a critical medical procedure, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fetzer Medical GmbH & Co. KG is recalling 174 units of 16600 / Fetzer Surgical Luikart Simpson OB Forceps 14" (35.5cm), Item No./Product Code 46-5050. The recall involves specific lot numbers: 17302220, 17303061, 17303062, and 17303063.
The recall was initiated after reports that doctors were unable to pull the obstetric forceps apart. This functional defect could interfere with the intended use of the instrument during difficult vaginal births.
The affected products were distributed in the United States to the states of Illinois and Virginia. Healthcare providers and consumers should stop using the affected forceps and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to…
- Manufacturer
- Fetzer Medical GmbH & Co. KG
- Hazard
- Affected units
- 174
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)
- Lot Numbers: 17302220
- 17303061
- 17303062 and 17303063
Distribution
Part of a larger recall action
This product is one of 4 recalled by Fetzer Medical GmbH & Co. KG 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 4 products in this recall →Related recalls
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