The Recall Desk
HighFDA (Devices)·Z-0758-2019·Announced 2019-01-30

Fetzer Medical Recalls Simpson OB Forceps Due to Functional Defect

Fetzer Medical is recalling 2 units of Simpson OB Forceps because doctors reported being unable to pull the instruments apart.

What this means for you

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 intended use during a critical medical procedure, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Fetzer Medical GmbH & Co. KG is recalling 2 units of 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040. The recall is associated with Lot Number 13300956.

The firm initiated the recall after receiving a report that doctors were unable to pull the obstetric forceps apart. This functional defect could prevent the proper use of the instrument during difficult vaginal births.

The affected products were distributed in the United States to the states of Illinois and Virginia. Consumers and healthcare providers who possess these specific units should stop using them and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 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
Affected units
2

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 13300956

Distribution

Distributed in 2 states:

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 →

Same manufacturer · Fetzer Medical GmbH & Co. KG

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