The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1477-2022·Announced 2022-08-03

Medical Device Kits Recalled for Leaking Isopropyl Alcohol

Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.

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: FDA Class II medical device recall with a chemical hazard from leaking isopropyl alcohol bottles. The leaking chemical constitutes a risk-of-harm scenario without documented reported injuries, consistent with High severity under the recall rubric.

Plain-English summary

Medline Industries, LP is recalling medical device kits that contain leaking bottles of isopropyl alcohol. The recall affects approximately 28,745 units that have been distributed nationwide in the United States.

The affected kits include multiple models, including CDS981510J, CDS984260I, CDS984263L, DYNJ906469D, DYNJ908097, DYNJ906469B, and numerous other DYNJ model variants. Each affected model has specific affected lot numbers identified in the FDA recall notice.

Leaking isopropyl alcohol in the kits presents a chemical hazard. Consumers who have received affected kits should discontinue use immediately and contact Medline Industries for instructions regarding return or replacement of the recalled products.

The recalled product

Product
Z-1477-2022
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device
Hazard
Affected units
28,745

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)

  • a. Model CDS981510J
  • Lot Numbers: 22BDB532
  • b. Model CDS984260I
  • Lot Numbers: 22CBM678
  • 22CBM679
  • 21FBJ127
  • 21GBV813
  • 21KBA497
  • c. Model CDS984263L
  • Lot Numbers: 22DBD966
  • 22CBV297
  • 21GBV822
  • c. Model DYNJ906469D
  • Lot Numbers: 22DDA747
  • 22DDA652
  • 22CDC430
  • c. Model DYNJ908097
  • Lot Numbers: 22ABN864
  • 22BBU902
  • 22BBX706

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - SPT 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 8 products in this recall →

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