The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1619-2023·Announced 2023-05-31

Medical Device Spine Pack Light Handles May Separate During Surgical Use

Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.

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: FDA Class II recall for surgical equipment where handle covers may separate during use, potentially compromising sterile field and patient safety. Classified as a risk-of-harm device defect without documented injuries.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions Spine Pack kits (Reference AMS4599(C), containing P 2 Cover Light Handle Blue STE, Sterile EO). This recall affects 30 kits distributed in Massachusetts.

The light handle covers on these surgical packs may separate or detach from the light handle during procedure use. If a cover detaches, it could delay the surgical procedure and compromise the sterile field, potentially resulting in injury to the patient.

The affected lot numbers are 187143 and 188654. The product's UDI (Unique Device Identifier) is B098AMS4599C0. This is an FDA Class II recall.

The recalled product

Product
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Equipment
Hazard
Affected units
30

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 (2)

  • Lot #s 187143 and 188654
  • UDI: B098AMS4599C0

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Windstone Medical Packaging, Inc. 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 3 products in this recall →

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