Windstone Medical Packaging, Inc. Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Brand
Windstone Medical Packaging, Inc.
Lot Codes / Batch Numbers
Lot #s 187154 and 189008, UDI: B098AMS6539E0
Products Sold
Lot #s 187154 and 189008, UDI: B098AMS6539E0
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue S due to Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the ster. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Recommended Action
Per FDA guidance
On April 24, 2023, Aligned Medical Solutions issued a "Urgent: Medical Device Recall" notification via E-Mail. Customers were asked to take the following actions: 1. Immediately check your inventory for the voluntary recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for the all products affected by this recall. Packs will be labeled with a sticker attached to each pack. 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity 4. If you have further distributed this products, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to vdavis@alignedmedicalsolutions.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement STERIS product is needed. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA
Page updated: Jan 10, 2026