Agency classClass IIOur severity:High FDA (Devices)·Z-2108-2015·Announced 2015-07-29

FDA Recalls Devon Light Gloves for Sterility Compromising Defects

The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.

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 involves a medical device where sterility is compromised, posing a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Mini-Kits and Sterile-Kits containing the Devon Light Glove manufactured by Covidien LLC. The recall is due to the presence of splits or holes in the gloves, which compromises the sterility of the product. The affected units are identified by lot numbers beginning with 508xxxx or lower.

A total of 559,108 kits are included in this recall. The products were distributed nationwide in the United States, including the Virgin Islands, as well as in Canada, Australia, New Zealand, and numerous countries in Europe, the Middle East, Africa, and Asia. The specific catalog numbers and kit descriptions are listed in the FDA recall record Z-2108-2015.

Healthcare facilities and consumers should stop using the affected gloves immediately. Users should check their inventory for the specific lot numbers and catalog numbers listed in the official recall notice. For more information or to report adverse events, contact the FDA or the recalling firm, Covidien LLC.

The recalled product

Product: Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit…
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Gloves
Hazard: sterility-compromise
infection-risk
Affected units: 559,108

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 (1)

Lot number begins 508xxxx or lower

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same manufacturer · Covidien LLC

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · sterility compromise