Unimed Recalls Laparoscopic Electrode Hooks Due to Coating Material Changes
Unimed Surgical Products is recalling 120,416 laparoscopic electrode hooks due to changes in PTFE coating materials. The devices were distributed in Missouri, Tennessee, and Pennsylvania.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described as a concern regarding material changes without explicit evidence of harm, fitting the criteria for a moderate severity score.
Plain-English summary
Unimed Surgical Products, Inc. is recalling 120,416 units of the Progressive Medical Laparoscopic Electrode PTFE Coated L Hook 33cm. These medical devices are intended for the cutting of soft tissue and coagulation during laparoscopic procedures.
The recall was initiated due to concerns regarding changes that were made to the PTFE coating materials. The affected units were distributed in the states of Missouri, Tennessee, and Pennsylvania. The recall covers numerous specific lot numbers, including 071212-02, 071212-03, and 012913-09.
Healthcare facilities and consumers who have these specific devices should stop using them and contact Unimed Surgical Products, Inc. for further instructions on how to return or dispose of the equipment.
The recalled product
- Product
- PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
- Manufacturer
- Unimed Surgical Products, Inc.
- Hazard
- Affected units
- 120,416
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)
- Lot Numbers: 071212-02
- 071212-03
- 071212-05
- 071212-01
- 071212-06
- 082712-02
- 071212-04
- 082712-04
- 082712-05
- 082712-13
- 071212-07
- 082712-07
- 082712-09
- 082712-03
- 082712-15
- 082712-14
- 081712-06
- 082712-01
- 082712-10
- 081512-06
Distribution
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