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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Resection Sheaths Recalled for Breaking Ceramic Tips

Agency Publication Date: February 20, 2026
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Summary

Olympus Corporation of the Americas has recalled 26,822 resection sheaths and inner sheaths used in urological and gynecological procedures. The recall was initiated because the ceramic tips on these sheaths can break during use, which could leave fragments inside a patient or cause the device to malfunction. These medical devices were distributed nationwide across the United States.

Risk

A broken ceramic tip could result in sharp fragments entering the patient's body or cause the device to fail during a critical surgical procedure, potentially leading to internal injury or surgical delays.

What You Should Do

  1. Identify if your facility has any of the affected Olympus Resection Sheaths by checking the model and UDI numbers on the device packaging.
  2. Affected models include A22014A, A22014T, A22040A, A22040T, A22041A, A22041T, A22042A, A22042T, A22043A, A22043T, A2660, A42011A, A4741, WA22017A, WA22017T, A2666, A2660T, A37004A, A2641, A2642, and A2666T. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus Resection Sheath
Variants: Urological applications
Model / REF:
A22014A
A22014T
Lot Numbers:
All lots
UDI:
04042761020893
04042761020909

Recall #: Z-1438-2026; Quantity: 29 units

Product: Olympus Resection Inner Sheath (for 26 Fr. Outer Sheath)
Variants: Urological applications
Model / REF:
A22040A
Lot Numbers:
All Lots
UDI:
04042761029339

Recall #: Z-1439-2026; Quantity: 6,949 units

Product: Olympus Resection Inner Sheath (for 26 Fr. Outer Sheath)
Variants: Urological applications
Model / REF:
A22040T
Lot Numbers:
All Lots
UDI:
04042761029360

Recall #: Z-1440-2026; Quantity: 7,426 units

Product: Olympus Resection Sheath (24 Fr)
Variants: Urological applications
Model / REF:
A22041A
Lot Numbers:
All Lots
UDI:
04042761020961

Recall #: Z-1441-2026; Quantity: 3,484 units

Product: Olympus Resection Sheath (24 Fr., with Deflecting Obturator)
Variants: Urological applications
Model / REF:
A22041T
Lot Numbers:
All Lots
UDI:
04042761020978

Recall #: Z-1442-2026; Quantity: 2,626 units

Product: Olympus Resection Sheath (26 Fr.)
Variants: Urological applications
Model / REF:
A22042A
Lot Numbers:
All Lots
UDI:
04042761020985

Recall #: Z-1443-2026; Quantity: 1,676 units

Product: Olympus Resection Sheath (26 Fr. with Deflecting Obturator)
Variants: Urological applications
Model / REF:
A22042T
Lot Numbers:
All Lots
UDI:
04042761020992

Recall #: Z-1444-2026; Quantity: 1,634 units

Product: Olympus Resection Sheath (28 Fr.)
Variants: Urological applications
Model / REF:
A22043A
Lot Numbers:
All Lots
UDI:
04042761021005

Recall #: Z-1445-2026; Quantity: 118 units

Product: Olympus Resection Sheath (28 Fr. with Deflecting Obturator)
Variants: Urological applications
Model / REF:
A22043T
Lot Numbers:
All Lots
UDI:
04042761021012

Recall #: Z-1446-2026; Quantity: 207 units

Product: Olympus Inner Sheath
Variants: Urological applications
Model / REF:
A2660
Lot Numbers:
All Lots
UDI:
04042761004176

Recall #: Z-1447-2026; Quantity: 9 units

Product: Olympus Resection Sheath (8 mm)
Variants: Gynecological applications
Model / REF:
A42011A
Lot Numbers:
All Lots
UDI:
04042761023658

Recall #: Z-1448-2026; Quantity: 899 units

Product: Olympus Inner Sheath
Variants: Gynecological applications
Model / REF:
A4741
Lot Numbers:
All Lots
UDI:
04042761006514

Recall #: Z-1449-2026; Quantity: 91 units

Product: Olympus Inner Sheath (Long)
Variants: Urological and gynecological applications
Model / REF:
WA22017A
Lot Numbers:
All Lots
UDI:
04042761051514

Recall #: Z-1450-2026; Quantity: 437 units

Product: Olympus Inner Sheath (Long)
Variants: Urological and gynecological applications
Model / REF:
WA22017T
Lot Numbers:
All Lots
UDI:
04042761051521

Recall #: Z-1451-2026; Quantity: 1,141 units

Product: Olympus Resection Sheath
Variants: Urologic applications
Model / REF:
A2666
Lot Numbers:
All Lots
UDI:
04042761004244

Recall #: Z-1452-2026; Quantity: 1 unit

Product: Olympus Inner Sheath (21 Fr.)
Variants: Urological applications
Model / REF:
A2660T
Lot Numbers:
All Lots
UDI:
04042761004183

Recall #: Z-1453-2026; Quantity: 1 unit

Product: Olympus Sheath (10 Fr.)
Variants: Urological applications
Model / REF:
A37004A
Lot Numbers:
All Lots
UDI:
04042761023092

Recall #: Z-1454-2026; Quantity: 94 units

Product: Olympus Inner Sheath
Variants: Urological applications
Model / REF:
A2641
Lot Numbers:
All Lots
UDI:
04042761004060

Recall #: Z-1455-2026; Quantity: 0 units

Product: Olympus Inner Sheath
Variants: Urological applications
Model / REF:
A2642
Lot Numbers:
All Lots
UDI:
04042761004084

Recall #: Z-1456-2026; Quantity: 0 units

Product: Olympus Resection Sheath
Variants: Urological applications
Model / REF:
A2666T
Lot Numbers:
All Lots
UDI:
04042761004251

Recall #: Z-1457-2026; Quantity: 0 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98288
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized medical distributors; Direct medical sales
Manufactured In: United States
Units Affected: 20 products (29 units; 6,949 units; 7,426 units; 3,484 units; 2,626 units; 1,676 units; 1,634 units; 118 units; 207 units; 9 units; 899 units; 91 units; 437 units; 1,141 units; 1 unit; 1 unit; 94 units; 0 units; 0 units; 0 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.