Medline Recalls LASER CDS Surgical Packs with Non-Sterile Applicators
Medline Industries is recalling 144 LASER CDS surgical kits because specific ChloraPrep applicators were not sterilized. The non-sterile components were inadvertently released to California and New Mexico.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the use of non-sterile components in a surgical setting, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries, Inc. is recalling 144 kits of LASER CDS surgical packs. The recall involves specific kit components (numbers 29183, 52115, 82279, and 82281) labeled as "ChloraPrep" applicators. These components contain 2% chlorhexidine gluconate in 70% isopropyl alcohol and are used for skin preparation before procedures.
During assembly, these specific components were not placed in the sterile portion of the pack and were therefore not exposed to the ethylene oxide sterilization process. As a result, they were released in a non-sterile state. The remainder of the pack components were properly sterilized and are not affected.
The affected products were distributed to California and New Mexico. The specific model is CDS980970D, and the affected lot numbers are 16FD2090, 16GD2340, 16ID0038, 16KD1940, 17BD1440, and 17CD2208. Users should check their inventory for these specific lot numbers and component types.
The recalled product
- Product
- LASER CDS
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 144
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 (7)
- Model: CDS980970D
- Lots: 16FD2090
- 16GD2340
- 16ID0038
- 16KD1940
- 17BD1440
- 17CD2208
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, Inc. 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 5 products in this recall →Related recalls
Same manufacturer · Medline Industries, Inc.
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- SevereMedline Prep Kits Recalled Due to Non-Sterile Components
FDA (Devices) · 2024-03-06
- HighMedline Sterile Hand Pack recalled for inadequate sterilization
FDA (Devices) · 2023-03-01
- HighMedline Convenience Kits Recalled for Potential Applicator Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled Due to Potential Packaging Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Recalls Cataract Preop Kits with Potentially Contaminated Applicators
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential ChloraPrep Applicator Contamination
FDA (Devices) · 2026-09-09