The Recall Desk
HighFDA (Devices)·Z-2767-2020·Announced 2020-08-12

Boss Instruments Recalls DeBakey Needle Holders Due to Plate Breakage Risk

Boss Instruments is recalling 96 DeBakey needle holders because the tungsten carbide plate can break under pressure, posing a risk to patients and medical staff.

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 is classified as FDA Class II. The hazard involves a component breaking under pressure, which poses a risk of harm to patients or staff, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Boss Instruments, Ltd. is recalling 96 units of the BOSS DeBakey "Gator-Grip" Needle Holder, 2 mm tip, 9 inches, Part Numbers 50-2503 and 51-2503. The recall is due to a defect where the tungsten carbide plate, intended to hold the sewing needle securely, can break when the needle is held under pressure.

The affected devices were distributed worldwide, including nationwide in the United States and in specific states such as California, Tennessee, and Texas. International distribution included England, Japan, New Zealand, South Africa, South Korea, and Taiwan. Specific lot numbers associated with the recall include 00351415, 00425391, 00374008, 07702195, 08801812, 08802271, 00383211, 00384765, 00418258, 08804204, 09900093, and 09900383.

Healthcare facilities and users should stop using these specific needle holders immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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 p
Manufacturer
Boss Instruments, Ltd.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
96

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 (12)

  • Lot Numbers: 00351415
  • 00425391
  • 00374008
  • 07702195
  • 08801812
  • 08802271
  • 00383211
  • 00384765
  • 00418258
  • 08804204
  • 09900093
  • 09900383

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same hazard · component breakage

See all →