Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published December 22, 2021

FlexDex Needle Driver Recall: Stop Using Damaged Packaging

FlexDex Inc. recalls 8mm FlexDex Needle Driver (FD-335 ND) due to risk of injury from damaged packaging. Check for pinholes or tears in the pouch before use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0531-2022Medical deviceFlexD: Inc. ›
Take action

Contact the company

Recalling firmFlexDex Inc.10421 Citation Dr Ste 900 · Brighton, MI 48116-6558
✎ GovInfoNow plain-language explainer

FlexDex Inc. is recalling all 8mm FlexDex Needle Drivers with product code FD-335 ND because damaged packaging could lead to injury. If the packaging has pinholes or tears, do not use the product. Read more at govinfonow.com/recall/61390-flexdex-needle-driver-recall-stop-using-damaged-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/61390-flexdex-needle-driver-recall-stop-using-damaged-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0531-2022

Cite this page

“FlexDex Needle Driver Recall: Stop Using Damaged Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61390-flexdex-needle-driver-recall-stop-using-damaged-packaging. Based on FDA recall #Z-0531-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2022%22&limit=1).

The FDA announced on Dec. 22, 2021, that FlexDex Inc. is recalling its 8mm FlexDex Needle Driver (Product Code FD-335 ND) due to potential packaging damage. The firm is reinforcing instructions not to use the device if the package shows any damage, including pinholes or tears.

How to tell if you have it

  • Brand: FlexDex Inc.
  • Product: 8mm FlexDex Needle Driver
  • Product Code: FD-335 ND
  • Quantity: 273 units
  • Lots: All lots

The hazard

The recall addresses the risk of using the device if the sterile packaging is compromised. The firm states that any observed damage to the pouch, such as pinholes or tears, means the product should not be used.

Context

GovInfoNow's records show FlexDex Inc. has had other recent recalls of similar products include Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24), Medline 5.5" Sterile Scissors Recall (2025-11-13) and Medline Convenience Kits Recall (2026-06-12).

How to tell if you have this one

Check for pinholes or tears in the packaging pouch. The product is identified by the brand FlexDex and product code FD-335 ND.

  • Brand
    FlexD: Inc.
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging for Damage

    Inspect the packaging for pinholes or tears in the pouch. If damage is found, do not use the product.

How this recall unfolded

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Dec 22, 202112. FDA classified it Class II: Jan 27, 202223. Published in FDA’s Enforcement Report: Feb 2, 202234. FDA terminated the recall: Jul 25, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0531-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0531-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA