Z-1621-2023Class II

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Name: Z-1621-2023 Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Creator: Windstone Medical Packaging, Inc.
Published: 2023-04-24
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2023-04-24 / Open, Classified / root cause: sterility

FDA source

Windstone Medical Packaging, Inc. began a recall of Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO on 2023-04-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1621-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-24
Posted: 2023-05-23
Recalling firm: Windstone Medical Packaging, Inc.
Product: Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: 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
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: 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 [email protected] 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.
Quantity in commerce: 60 kits
Distribution: US: MA OUS: None
Product codes and lots: Lot 188843; UDI: B098AMS4601E0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1621-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1619-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23
Z-1620-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23
Z-1621-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)