FDA Recalls Improve Blood Collection Sets Due to Needle Defects
Guangzhou Improve Medical Instruments is recalling 700,000 blood collection sets in Puerto Rico due to needle defects including discoloration and gel agglomeration.
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 is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The defects (discoloration, gel agglomeration) present a risk of harm, but no specific injuries or illnesses are reported in the source text, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO. The recall involves 700,000 units distributed in Puerto Rico. The affected products are identified by Serial Number 102030132 and Lots #20150210 and #20150410.
The recall was initiated due to complaints that the needles are not smooth, exhibit discoloration, and have gel agglomeration on the needle tip. These defects may affect the functionality and safety of the medical device during use.
Consumers and healthcare facilities should stop using the affected blood collection sets immediately. The recalling firm, Guangzhou Improve Medical Instruments Co., Ltd., is responsible for managing the recall. Users should contact the manufacturer for further instructions on returning or disposing of the products.
The recalled product
- Product
- Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3)…
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd.
- Affected units
- 700,000
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)
- Serial Number 102030132 Lots #'s: 20150210 and 20150410
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Guangzhou Improve Medical Instruments Co., Ltd.
See all →- HighFDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment
FDA (Devices) · 2019-05-01
- HighFDA Recalls Prevent G Safety Winged Blood Collection Sets Due to Leaks
FDA (Devices) · 2018-08-01
Other medical device recalls
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment
FDA (Devices) · 2019-05-01
- HighFDA Recalls Prevent G Safety Winged Blood Collection Sets Due to Leaks
FDA (Devices) · 2018-08-01
- HighGlobal Healthcare Recalls VacuFlow Safe Blood Collection Sets
FDA (Devices) · 2016-09-28
- ModerateICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
FDA (Devices) · 2018-08-15
- HighGreiner Bio-One Recalls VACUETTE Safety Blood Collection Sets
FDA (Devices) · 2013-02-27
- ModerateFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16