CLASS II Device recall · Reported 30 Jan 2019 · FDA Enforcement Report
12002 / Boss Instruments Simpson OB Forceps, short recalled
Fetzer Medical GmbH & Co. KG is recalling 12002 / Boss Instruments Simpson OB Forceps, short, distributed in Illinois, Virginia. The recall was initiated on 28 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0758-2019
- FDA event ID
- 81873
- Recalling firm
- Fetzer Medical GmbH & Co. KG, Tuttlingen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2018
- FDA classified
- 18 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 28 Dec 2018 | Recall initiated by company | |
| 18 Jan 2019 | Classified by FDA | +21 days |
| 30 Jan 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Product as listed by the FDA
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 to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
Where it was distributed
US Distribution to states of: IL and VA.
Questions about this recall
Why was it recalled?
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Which lots are affected?
Lot Number 13300956
Where was it sold?
US Distribution to states of: IL and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 81873| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" recalled | Fetzer Medical GmbH & Co. KG | Other | IL, VA | |
| CLASS II | 12002 / Boss Instruments Ltd recalled by Fetzer Medical GmbH & Co. KG | Fetzer Medical GmbH & Co. KG | Other | IL, VA | |
| CLASS II | 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" recalled | Fetzer Medical GmbH & Co. KG | Other | IL, VA |
More recalls from Fetzer Medical GmbH & Co. KG
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" recalled | Fetzer Medical GmbH & Co. KG | Other | IL, VA |
| Device | CLASS II | 12002 / Boss Instruments Ltd recalled by Fetzer Medical GmbH & Co. KG | Fetzer Medical GmbH & Co. KG | Other | IL, VA |
| Device | CLASS II | 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" recalled | Fetzer Medical GmbH & Co. KG | Other | IL, VA |
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |