The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3202-2018·Announced 2018-09-26

ShinChang Recalls Disposable Insulin Syringes Due to Barrel Cracks

ShinChang Medical Co., Ltd. is recalling 6,570,800 disposable insulin syringes because a small crack was found in the top end of the barrel near the needle.

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. The defect presents a risk of harm to users of a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

ShinChang Medical Co., Ltd. is recalling 6,570,800 units of Disposable Insulin Syringes 0.3mL in three different sizes: 29Gx1/2, 30Gx5/16, and 31G x 5/16. The recall involves syringes sold under various brand names, including GNP, Healthmart, Kroger, Leader, Nipro, Sunmark, Lite Touch, and McKesson.

The defect consists of a small crack in the top end of the barrel near the needle. The affected products were distributed in Florida, Tennessee, and Virginia.

Consumers should stop using the recalled syringes and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
Manufacturer
ShinChang Medical Co., Ltd.
Category
Medical Device — Syringes
Hazard
Affected units
6,570,800

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 (20)

  • GNP Insulin Syringe 0.3mL 31G¿5/16" NP18127
  • Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18155
  • Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18186
  • Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18082
  • Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18083
  • Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18126
  • Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18146
  • Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18157
  • Leader Insulin Syringe 0.3mL 31G¿5/16" NP18123
  • Leader Insulin Syringe 0.3mL 31G¿5/16" NP18130
  • Leader Insulin Syringe 0.3mL 30G¿5/16" NP18151
  • Leader Insulin Syringe 0.3mL 31G¿5/16" NP18161
  • Leader Insulin Syringe 0.3mL 30G¿5/16" NP18180
  • Leader Insulin Syringe 0.3mL 31G¿5/16" NP18202
  • Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18128
  • Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18136
  • Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18166
  • Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18206
  • Lite Touch Insulin Syringe 0.3mL 30G¿5/16" LT1805
  • and McKesson Insulin Syringe 0.3mL 31G¿5/16" KSH0603.

Distribution

Distributed in 3 states:

Related recalls

Same hazard · structural defect

See all →

Similar recalls