Agency classClass IIOur severity:High FDA (Devices)·Z-2496-2019·Announced 2019-09-18

Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns

Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.

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 involves a medical device with a potential sterility failure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments (Reference PL730SU) intended for use in general surgery and gynecologic procedures. The recall involves 3 units from Lot 837B and Lot 109C. The distribution was nationwide in the United States, specifically within the state of California.

The recall was initiated because of a possibility that the sterility batch was insufficiently sterilized. This defect could potentially compromise the safety of the medical instruments during surgical procedures.

Healthcare facilities and consumers who have these specific instruments should stop using them immediately. They should contact Aesculap Implant Systems LLC for further instructions on how to return or dispose of the affected products.

The recalled product

Product: CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Manufacturer: Aesculap Implant Systems LLC
Category: Medical Device — Surgical Instruments
Hazard: sterility-failure
infection-risk

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 (1)

Lot # 109C and 837B

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Aesculap Implant Systems LLC

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Same hazard · sterility failure