Class II U.S. Food and Drug Administration

Stryker Sustainability Solutions Harmonic Focus Shears + Adaptive Tissue Technology recall: Due to manufacturing issue, reprocessed shears

Recall published 11 months ago

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0490-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Sustainability Solutions
Product type
Medical devices
Units affected
22, 476 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: (01)37613327348249/ 162xxxxx Lot Numbers: 16275164 16284043 16288055 16294327 16296918 163xxxxx Lot Numbers: 16301496 16305751 16306347 16306436 16316531 16316651 16342389 16343642 16346325 16346612 16347602 16348678 16349187 16353884 16355545 16357189 16360679 16363788 16366396 16367903 16368245 16375951 16376461 16378500 16380079 16382574 16383957 16386402 16399914 164xxxxx Lot Numbers: 16405308 16407386 16408732 16410690 16413617 16413975 16416261 16418939 16420520 16422830 16432199 16432342 16436871 16436987 16442725 16444477 16446841 16448857 16449208 16449296 16453140 16459248 16463302 16464895 16467199 16471023 16475746 16482558 16487182 16488252 16491206 16492941 16494926 16497950 16498718 165xxxxx Lot Numbers: 16502233 16503856 16506269 16507481 16511866 16511995 16514496 16514579 16520053 16521262 16521892 16522603 16527022 16527858 16530602 16531805 16534581 16535595 16538257 16539232 16540322 16540636 16549592 16551658 16554621 16559625 16567068 16567902 16569680 16573872 16575403 16576366 16576418 16579676 16583068 16585378 16587095 16587292 16592009 16592273 16595099 16595611 16598700 166xxxxx Lot Numbers: 16602578 16604258 16607822 16612246 16614330 16617406 16625703 16630079 16630328 16632353 16636528 16640175 16641167 16644299 16645144 16645768 16649786 16652064 16655193 16656536 16659901 16661415 16664176 16681913 16683266 16690151 16693679 167xxxxx Lot Numbers: 16705748 16759491 16762280 16763927 16766282 16767078 16768138 16768724 16769146 16775982 16778745 16779900 16795717 16796578 16797254 16797381 16797381 16799710 168xxxxx Lot Numbers: 16801351 16801564 16804498 16806005 16821036 16828177 16843649 16844103 16848493 16852781 16864607 16867268 16881353 16888650 16895321 16898535 169xxxxx Lot Numbers: 16910107 16913454 16920690 16928682 16931180 16935100 16945644 16951372 16962742 16967419 16969395 16977884 16979276 16981365 16988861 16991698 16993581 16996795 170xxxxx Lot Numbers: 17001825 17009610 17012825 17016204 17021294
UPC codes
37613327348249

Products covered by this recall

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 37613327348249

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 476 units

Model or item number

On the rating label, the box or the instruction sheet.

  • HAR9F
  • STERILEEO

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Stryker Sustainability Solutions — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Stryker Sustainability Solutions — 1810 W Drake Dr, Tempe, AZ, 85283-4327

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Stryker Sustainability Solutions medical devices recalled?

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 37613327348249; lot code 476 units; model number HAR9F, STERILEEO. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls