Medtronic recalls two pediatric insertion kit models due to label mix-up causing incorrect guidewire in kits. Affected kits have specific serial numbers and GTINs.
“Medtronic Bio-Medicus Insertion Kits: Label Mix-Up Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61801-medtronic-bio-medicus-insertion-kits-label-mix-up-risk. Based on FDA recall #Z-0003-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2022%22&limit=1).
The FDA announced on 2021-09-13 that Medtronic Perfusion Systems is recalling specific Bio-Medicus Insertion Kits due to a label mix-up resulting in incorrect guidewires being contained in the kits. The agency issued recall number Z-0003-2022 for the voluntary Class II action.
How to tell if you have it
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551
UPC 20763000115986
UPC 20763000116006
The hazard
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers, according to the FDA.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since 2017-06-22. Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04), Medline EYE TRAY-LF Kit Recall: Wrong Syringes Inside (2026-04-10), and Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard (2026-07-10).
How to tell if you have this one
Check for model numbers 96553 (Pediatric Insertion Kit) or 96551 (Venous Insertion Kit). Look for serial numbers 220719040 or 220641720 and GTINs 20763000116006 or 20763000115986.
Brand
Medtronic Perfusion Systems
Product
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Verify the model number on the kit packaging to confirm it is either 96553 or 96551.
Review Serial Numbers
Check for the specific serial numbers 220719040 (model 96553) or 220641720 (model 96551).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0003-2022 (September 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0003-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.