Agency classClass IIOur severity:High FDA (Devices)·Z-1450-2015·Announced 2015-04-22

CooperSurgical Recalls Wallach LL 100 Cryosurgical Units Due to Gas Line Burst Risk

CooperSurgical is recalling 255 Wallach LL 100 cryosurgical units because an internal gas line may malfunction and burst under pressure.

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 and involves a risk of harm (gas line burst) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

CooperSurgical, Inc. is recalling 255 units of Wallach LL 100 cryosurgical devices. The affected models include the LL100 Cryosurgical (Part Number 900001), LL110 with Pinned Yoke (Part Number 900019-70), LL100 Multi Tip W/TC (Part Number 900629), and LL100 - CO2 (Part Number 900162).

The recall is being conducted because the internal gas line may malfunction, causing the line to burst under pressure. The FDA has classified this recall as Class II, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected units were distributed nationwide to 38 states and the District of Columbia, as well as to Canada, Colombia, El Salvador, England, Guatemala, Hong Kong, Indonesia, Singapore, and Zimbabwe. Specific serial numbers for the affected units are listed in the official recall documentation. Users should contact CooperSurgical for further instructions on how to proceed with the recall.

The recalled product

Product: WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Cryosurgical Equipment
Hazard: pressure-burst
gas-leak
Affected units: 255

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)

Serial Numbers: 0414003
0414004
0414005
0414009
0414010
041404
0514001
0514002
0514003
0514004
0514005
0514006
0514007
0514008
0514009
0514010
0514011
0514012
0514013
0514014

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Same manufacturer · CooperSurgical, Inc.

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