Richard Wolf Artholine Punch B 4, 6MM H 1, 6MM Recalled for Potential Injury Risk
Richard Wolf GmbH is recalling 12 units of Artholine Punch B 4, 6MM H 1, 6MM because a potential burr in the joint may increase the risk of injury when the device is opened.
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 is classified as FDA Class II and involves a risk-of-harm product (potential injury from a burr) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Richard Wolf GmbH is recalling 12 units of the Artholine Punch B 4, 6MM H 1, 6MM. This medical device is used for the removal of soft tissue, cartilage tissue, or other non-osseous tissue via natural or surgically created passages. The specific product number is 89140.0105 and the lot number is 4500197481.
The recall was initiated because the punch may have a burr in one section of the joint. When the punch is open, this defect creates an increased potential for injury. The agency has classified this as a Class II recall.
The affected units were distributed worldwide to Germany, Hong Kong, Ireland, Romania, and Turkey. Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage…
- Manufacturer
- Richard Wolf GmbH
- Hazard
- Affected units
- 12
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 (2)
- Product Number 89140.0105
- Lot Number 4500197481
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Richard Wolf GmbH
See all →- ModeratePiezoWave 2 Control Unit therapeutic massager high voltage capacitor failure
FDA (Devices) · 2025-05-21
- HighBiopsy forceps may fail to open when endoscope is bent
FDA (Devices) · 2023-05-03
- HighSurgical forceps may fail to open when endoscope shaft is bent
FDA (Devices) · 2023-05-03
- HighSurgical forceps may fail to open during endoscopic procedures
FDA (Devices) · 2023-05-03
- HighEndoscopic Forceps May Fail to Open When Shaft Bent
FDA (Devices) · 2023-05-03
Same hazard · injury
See all →- HighHonda Recalls Hybrid and Fuel Cell Vehicles for Tire Repair Kit Defect
NHTSA · 2026-10-08
- HighGreenpower Recalls 2021 Nano Beast School Buses Due to Software Error
NHTSA · 2026-10-05
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighGreenpower Recalls EV Star Buses Due to Software Error
NHTSA · 2026-09-30
- HighVolvo Bus 9700 Recall for Missing Emergency Exit Instructions
NHTSA · 2026-09-18
Similar recalls
- HighRichard Wolf Reusable Rotary Blade Recall Due to Weak Welds
FDA (Devices) · 2016-02-17
- HighRichard Wolf Reusable Rotary Blade Recalled for Weak Welds
FDA (Devices) · 2016-02-17
- HighArthroCare Knot Pusher Recalled Due to Sharp Edge Hazard
FDA (Devices) · 2014-01-15
- ModerateRichard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects
FDA (Devices) · 2019-02-13
- HighArthrex Burr Recalled for Excessive Heat Generation During Use
FDA (Devices) · 2019-05-01
- ModerateStryker Round Fluted Bur Recall Due to Missing Notches
FDA (Devices) · 2014-06-18