Z-0774-2022Class II

JAGTOME RX 44-20-450-035 Material Number: M00573050

Name: Z-0774-2022 JAGTOME RX 44-20-450-035 Material Number: M00573050
Creator: Boston Scientific Corporation
Published: 2021-12-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-12-22 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of JAGTOME RX 44-20-450-035 Material Number: M00573050 on 2021-12-22. FDA classified it as Class II and gives the reason as "Sterility of device is compromised due to a sterile barrier breach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0774-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-22
Posted: 2022-03-11
Recalling firm: Boston Scientific Corporation
Product: JAGTOME RX 44-20-450-035 Material Number: M00573050
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Sterility of device is compromised due to a sterile barrier breach
Root cause tag: packaging
FDA root cause: Packaging process control
Action: BSC issued Urgent Medical Device Product Removal - Immediate Action Required on December 16, 2021. Letter states reason for recall, health risk and action to take: The Reply Verification Tracking Form enclosed with this letter must be completed and returned even if you do not have any product from the affected lot/batches. 1. Immediately discontinue use of and segregate affected product. " Immediately remove all affected product from your inventory. " Segregate this product in a secure location for return to Boston Scientific. 2. You must complete and email or fax your Reply Verification Tracking Form(s) immediately to get an RGA # before you return any product. " Indicate on your RVTF the quantity of units from each lot/batch that you will be returning. " Return the RVTF as described below: Email: [email protected] or Fax to: Field Action Center 1-866-213-1806 You will be contacted by Boston Scientific and provided a Returned Goods Authorization (RGA) Number within 24-48 hours after your RVTF is received " Report all inventory to be returned and report in single-unit quantity(ies), not boxes. " NOTE: If you have responded to this Removal to anyone other than Boston Scientific, we would not have received your response. Please respond using the email/fax information provided above. Credits will be issued for all affected product that is properly returned to Boston Scientific. 3. Package/Ship the Affected Product. " Package any product that is being returned in an appropriate shipping box. " Affix the enclosed (red/white) return address label to the outside of the box. " Write the RGA number in large print on the outside of the box, on the return address label. " Feel free to use our Federal Express Number 9205-2515-6 to return this package via second day delivery. " Seal the box, and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 0217
Quantity in commerce: 3578 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Product codes and lots: Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0774-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0752-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0753-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0754-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0755-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0756-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0757-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0758-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0759-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0760-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0761-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0762-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0763-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0764-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0765-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0766-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0767-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0768-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0769-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0770-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0771-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0772-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0773-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0774-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0775-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0776-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0777-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0778-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0779-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0780-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11
Z-0781-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-23	2022-03-11

Product code KNS

K013153Class IIAutotome Rx Model # 4515, 4516Boston Scientific Corp / cleared 2001-10-19

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)