Food, drugs, devices › Leica Microsystems, Inc.
Device recall: BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
FDA enforcement event 81036 is a device recall by Leica Microsystems, Inc. of Buffalo Grove, IL, initiated 17 Sep 2018 and classified Class II, with 1 product record.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 21 Aug 2020. Initiation: voluntary: firm initiated. Leica Microsystems, Inc. has 33 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Leica Microsystems, Inc., Buffalo Grove, IL.
Reason for recall
"The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound."
Distribution
"Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0281-2019 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments | 876 devices (in U.S. and Canada) | Class II | Terminated | 7 Nov 2018 |
Context
Other enforcement events for Leica Microsystems, Inc.
All 33 events for Leica Microsystems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.