Food, drugs, devices › Microline Surgical, Inc.
Device recall: TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Microline Surgical, Inc. (Beverly, MA) initiated this device recall on 22 Mar 2019; FDA lists 1 product record under event 82708, classified Class II.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 30 Jul 2020. Initiation: voluntary: firm initiated. Microline Surgical, Inc. has 5 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
Microline Surgical, Inc., Beverly, MA.
Reason for recall
"The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures."
Distribution
"The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1698-2019 | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | 115 units | Class II | Terminated | 12 Jun 2019 |
Context
Other enforcement events for Microline Surgical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Nov 2024 | Microscissor Tip (Disposable); Microline Catalog #: 3122. | Device | Class II | 1 |
| 1 Nov 2017 | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disp | Device | Class II | 2 |
| 13 Jul 2017 | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicat | Device | Class II | 1 |
| 12 May 2014 | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 | Device | Class II | 2 |
All 5 events for Microline Surgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures."
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: "The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jul 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.