WALLACH LL 100 cryosurgical units: LL100 Cryosurgical — Class II medical device recall Z-1450-2015
Terminated recall by CooperSurgical, Inc., reported 2015-04-22, distributed nationwide. Internal gas line may malfunction causing the line to burst under pressure.
| Recall number | Z-1450-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-04-16 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2016-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CO, GB, GT, HK, ID, SG, SV |
| Quantity | 255 units |
| Reason classes | device malfunction |
| Serial numbers | 0414003, 0414004, 0414005, 0414009, 0414010, 041404, 0514001, 0514002, 0514003, 0514004, 0514005, 0514006, 0514007, 0514008, 0514009, 0514010, 0514011, 0514012, 0514013, 0514014, 0514015, 0514016, 0514017, 0514018, 0514019 and 230 more |
| Model numbers | 900001, 900019-70, 900162, 900629 |
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
Reason for recall
Internal gas line may malfunction causing the line to burst under pressure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1450-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.