CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
BOSS DeBakey "Gator-Grip" Needle Holder tip, 9" recalled
Boss Instruments is recalling BOSS DeBakey "Gator-Grip" Needle Holder tip, 9", Part Numbers 50-2503 and 51-2503, distributed nationwide in the US. The recall was initiated on 26 Jun 2020 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-2767-2020
- FDA event ID
- 86040
- Recalling firm
- Boss Instruments, Zion Crossroads, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2020
- FDA classified
- 5 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 26 Jun 2020 | Recall initiated by company | |
| 5 Aug 2020 | Classified by FDA | +40 days |
| 12 Aug 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
Questions about this recall
Is BOSS DeBakey "Gator-Grip" Needle Holder tip, 9", Part Numbers 50-2503 and 51-2503 recalled?
Yes. Boss Instruments recalled BOSS DeBakey "Gator-Grip" Needle Holder tip, 9", Part Numbers 50-2503 and 51-2503 on 26 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2767-2020.
Why was it recalled?
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Which lots are affected?
Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
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 21 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 Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | 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 | Sterility | Nationwide |