Stradis Healthcare Recalls Breast Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling nine Breast Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
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 surgical medical device component (gloves) that is being recalled by the primary manufacturer. While no specific injuries are reported in the text, the use of recalled components in surgery presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare, LLC. is recalling nine units of Breast Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.
The affected products were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. The products were also distributed to Canada and Dubai.
The specific pack codes involved in this recall are 693-196, 693-188, 693-166, 693-112, and 888-2583. Consumers and healthcare facilities should check their inventory for these specific pack codes and stop using the affected products immediately.
The recalled product
- Product
- Breast Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Affected units
- 9
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 (5)
- Pack 693-196
- 693-188
- 693-166
- 693-112
- 888-2583
Distribution
Part of a larger recall action
This product is one of 51 recalled by Stradis Healthcare, 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 51 products in this recall →Related recalls
Same manufacturer · Stradis Healthcare, LLC.
See all →- ModerateStradis Hand Pack Recall Due to Medtronic Glove Component Issue
FDA (Devices) · 2015-07-15
- ModerateStradis ENT Packs Recalled Due to Medtronic Glove Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Blepharoplasty Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- HighStradis Arthroscopy Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves
FDA (Devices) · 2015-07-15
Same hazard · contamination
See all →- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereFDA Recalls Sterile Surgical Kits with Compromised Gloves
FDA (Devices) · 2015-07-29
- HighSurgical Kits Recalled Due to Glove Splits Compromising Sterility
FDA (Devices) · 2015-07-29
- HighFDA Recalls Devon Light Gloves for Sterility Compromising Defects
FDA (Devices) · 2015-07-29
- ModerateBusse Breast Pack Surgical Instrument Tray Recalled for Labeling Update
FDA (Devices) · 2016-12-28
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2017-03-08
- HighFDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
FDA (Devices) · 2015-07-29