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Use caution Medical device recall · FDA · Published September 18, 2025

B Braun Perifix FX Epidural Tray Recall: Incorrect Lid Position Hazard

B Braun recalls Perifix FX epidural anesthesia trays with potential incorrect catheter connector lid position. Affected units include specific lot numbers and expiration dates. Contact for remedy details.

🇺🇸 FDA recall #Z-0116-2026Medical deviceB Braun ›
Take action

Contact the company

Recalling firmB BRAUN MEDICAL INC861 Marcon Blvd · Allentown, PA 18109-9577
✎ GovInfoNow plain-language explainer

B Braun is recalling Perifix FX continuous epidural anesthesia trays that may have a lid in the wrong position. This could lead to improper use during medical procedures if not corrected. Read more at govinfonow.com/recall/51252-b-braun-perifix-fx-epidural-tray-recall-incorrect-lid-position.

Source Summary by GovInfoNow · govinfonow.com/recall/51252-b-braun-perifix-fx-epidural-tray-recall-incorrect-lid-position · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0116-2026

Cite this page

“B Braun Perifix FX Epidural Tray Recall: Incorrect Lid Position Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51252-b-braun-perifix-fx-epidural-tray-recall-incorrect-lid-position. Based on FDA recall #Z-0116-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2026%22&limit=1).

B Braun Medical Inc. recalled PERIFIX FX Continuous Epidural Anesthesia Trays nationwide due to a potential for the catheter connector lid to be in the incorrect position, the FDA said on Sept. 18, 2025.

How to tell if you have it

  • Brand: B Braun
  • Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter
  • Product Code: CE17TKFC
  • REF: 332079
  • UDI-DI (Primary): 04046955899456
  • UDI-DI (Unit of Use): 04046955899463
  • Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110
  • Expiration Date: 07/31/2026
  • Quantity: 48,110 units

The hazard

The hazard is the potential for the lid of the catheter connector to be in the incorrect position.

Context

GovInfoNow's records show B Braun Medical Inc. has 66 other recalls on record since Oct. 15, 2013. Other recent recalls include a Sodium Chloride Injection recall for particulate matter hazard (Aug. 19, 2026), a Lactated Ringer's Injection recall for particulate matter hazard (Aug. 12, 2026), and a Discofix Four Way Stopcock recall for an incorrect expiration date (Aug. 4, 2026). Other recent recalls of similar products include a Medline Epidural Tray recall regarding lidocaine ampules risk (May 21, 2026) and Rocket Seldinger Catheter Tray recalls for risk of falling during use (Nov. 7, 2025).

How to tell if you have this one

Check for the product code CE17TKFC on the tray. Look for lot numbers starting with 0062010541 through 0062015114 and expiration date 07/31/2026.

  • Brand
    B Braun
  • Category
    Medical device
FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Recall numberProduct, codes & lotsQuantity
Z-0114-2026PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.; REF: 332077; Product Code: CE17TBFC; UDI-DI (Primary): 4046964177187; UDI-DI (Unit of Use): 4046964177170; Lot Number: 0062022053. Expiration Date: 10/16/20240 units
Z-0115-2026PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.; REF: 332078; Product Code: CE17TKFCPS; UDI-DI (Primary): 04046955899432; UDI-DI (Unit of Use): 04046955899449; Lot Numbers: 0062006314, 0062011670, 0062028428. Expiration Date: 07/31/20260 units
Z-0116-2026PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.; REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110. Expiration Date: 07/31/2026.48,110 units
Z-0117-2026PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY; REF: 332086; Product Code: CE17TKF; UDI-DI (Primary): 04046955900985; UDI-DI (Unit of Use): 04046955900992; Lot Number: 0062011669. Expiration Date: 07/31/2026.0 units
Z-0118-2026PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.; REF: 332093; Product Code: CE17TKFSDT; UDI-DI (Primary): 04046964954252; UDI-DI (Unit of Use): 04046964954245; Lot Number: 0062003112. Expiration Date: 07/31/2026.0 units
Z-0119-2026PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.; REF: 332097; Product Code: CE17TKFCS; UDI-DI (Primary): 04046955899470; UDI-DI (Unit of Use): 04046955899487; Lot Numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, 0062013052. Expiration Date: 07/31/2026.21,270 units
Z-0120-2026PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.; REF: 332098; Product Code: CE17TKFS; UDI-DI (Primary): 04046955901067; UDI-DI (Unit of Use): 04046955901074; Lot Numbers: 0062009622, 0062014350. Expiration Date: 07/31/2026.2,760 units
Z-0121-2026PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.; REF: 332238; Product Code: CE17TFC; UDI-DI (Primary): 04046964178603; UDI-DI (Unit of Use): 04046964178597; Lot Number: 0062014626. Expiration Date: 05/31/2028.0 units
Z-0122-2026ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.; REF: 333196; Product Code: ES1725KFX; UDI-DI (Primary): 04046955899531; UDI-DI (Unit of Use): 04046955899548; Lot Numbers: 0062005817, 0062011662, 0062011663, 0062014354, 0062011664. Expiration Date: 07/31/2026.10,130 units
Z-0123-2026Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA TUOHY 19GA SPRW OT.; REF: 333197; Product Code: NES1727KFX; UDI-DI (Primary): 04046964179327; UDI-DI (Unit of Use): 04046964179310; Lot Numbers: 0062000732, 0062012053. Expiration Date: 07/31/2026.2,840 units
Z-0124-2026Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.; 1. REF: 530029; Product Code: SESK; UDI-DI (Primary): 04046964305245; UDI-DI (Unit of Use): 04046964305238; Lot Number: 0062012031. 2. REF: 530048; Product Code: SESK; UDI-DI (Primary): 04046964305313; UDI-DI (Unit of Use): 04046964305306; Lot Number: 0062006298. 3. REF: 530155; Product Code: SESK; UDI-DI (Primary): 04046964306211; UDI-DI (Unit of Use): 04046964306204; Lot Number: 0062012054. 4. REF: 530159; Product Code: SESK; UDI-DI (Primary): 04046964669286; UDI-DI (Unit of Use): 04046964669279; Lot Number: 0062012025. 5. REF: 530169; Product Code: SESK; UDI-DI (Primary): 04046964808920; UDI-DI (Unit of Use): 04046964808913; Lot Number: 0062012035. 6. REF: 530171; Product Code: SESK; UDI-DI (Primary): 04046964950391; UDI-DI (Unit of Use): 04046964950384; Lot Number: 0062006303. 7. REF: 530180; Product Code: SESK; UDI-DI (Primary): 04046955156443; UDI-DI (Unit of Use): 04046955156436; Lot Number: 0062000738. 8. REF: 530197; Product Code: SESK; UDI-DI (Primary): 04046955619337; UDI-DI (Unit of Use): 04046955619320; Lot Number: 0062003710. 9. REF: 530194; Product Code: SESK; UDI-DI (Primary): 4046955589388; UDI-DI (Unit of Use): 4046955589371; Lot Number: 0062014360. 10. REF: 530199; Product Code: SESK; UDI-DI (Primary): 04046955619375; UDI-DI (Unit of Use): 04046955619368; Lot Number: 0062001876. 11. REF: 530160; Product Code: SESK; UDI-DI (Primary): 04046964813993; UDI-DI (Unit of Use): 04046964813986; Lot Number: 0062011011. 12. REF: 530184; Product Code: SESK; UDI-DI (Primary): 04046955156528; UDI-DI (Unit of Use): 04046955156511; Lot Number: 0062003228. Expiration Date: 07/31/2026.2,450 units
Z-0125-2026Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.; REF: 530185; Product Code: SESK; UDI-DI (Primary): 04046955625147; UDI-DI (Unit of Use): 04046955625130; Lot Number: 0062003227. Expiration Date: 07/31/2026.60 units
Z-0126-2026Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER. 12. CESK FLORIDA HOSPITAL. 13. CESK RIVERSIDE HEALTH SYSTEM. 14. CESK MAYO CLINIC OB. 15. CESK PRESBYTERIAN HOSPITAL DALLAS. 16. CESK HOUSTON METHODIST HOSPITAL. 17. CESK OHIO STATE UNIV MEDICAL CENTER. 18. CESK NORTONS WOMEN'S AND CHILDREN'S. 19. CESK BEN TAUB. 20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST. 21. CESK ALLEGHENY GENERAL HOSPITAL. 22. CESK UNIVERSITY OF ILLINOIS MED CTR. 23. CESK RUSH UNIVERSITY MEDICAL CENTER. 24. CESK ST. JOSEPH MEDICAL CENTER. 25. CESK INTEGRIS HEALTH. 26. CESK UMASS MEMORIAL. 27. CESK STANFORD UNIV HOSP 20054718. 28. CESK OVERLAKE HOSPITAL. 29. CESK CHRIST HOSPITAL 20057985. 30. CESK NEWTON-WELLESLEY HOSPITAL.; 1. REF: 551028; Product Code: CESK; UDI-DI (Primary): 04046964306334; UDI-DI (Unit of Use): 04046964306327; Lot Number: 0062017630. 2. REF: 551474; Product Code: CESK; UDI-DI (Primary): 04046964306938; UDI-DI (Unit of Use): 04046964306921; Lot Number: 0062006292. 3. REF: 551630; Product Code: CESK; UDI-DI (Primary): 04046964307560; UDI-DI (Unit of Use): 04046964307546; Lot Number: 0062017605. 4. REF: 551749: Product Code: CESK; UDI-DI (Primary): 04046964307942; UDI-DI (Unit of Use): 04046964307935; Lot Number: 0062017615. 5. REF: 551769: Product Code: CESK; UDI-DI (Primary): 04046964308024; UDI-DI (Unit of Use): 04046964308017; Lot Number: 0062006304. 6. REF: 551998: Product Code: CESK; UDI-DI (Primary): 04046964310942; UDI-DI (Unit of Use): 04046964310928; Lot Number: 0062014368. 7. REF: 552006: Product Code: CESK; UDI-DI (Primary): 04046964311215; UDI-DI (Unit of Use): 04046964311192; Lot Number: 0062013265. 8. REF: 552076: Product Code: CESK; UDI-DI (Primary): 04046964814013; UDI-DI (Unit of Use): 04046964814006; Lot Number: 0062003111. 9. REF: 552113: Product Code: CESK; UDI-DI (Primary): 04046964950193; UDI-DI (Unit of Use): 04046964950186; Lot Number: 0062006384. 10. REF: 552116: Product Code: CESK; UDI-DI (Primary): 04046964950254; UDI-DI (Unit of Use): 04046964950247; Lot Number: 0061994277. 11. REF: 552119: Product Code: CESK; UDI-DI (Primary): 04046964989780; UDI-DI (Unit of Use): 04046964989773; Lot Number: 0062017951. 12. REF: 552123: Product Code: CESK; UDI-DI (Primary): 04046955057788; UDI-DI (Unit of Use): 04046955057771; Lot Number: 0062003214. 13. REF: 552126: Product Code: CESK; UDI-DI (Primary): 04046955056903; UDI-DI (Unit of Use): 04046955056897; Lot Number: 0061999998. 14. REF: 552133: Product Code: CESK; UDI-DI (Primary): 04046955127801; UDI-DI (Unit of Use): 04046955127795; Lot Number: 0062012017. 15. REF: 552135: Product Code: CESK; UDI-DI (Primary): 04046955127849; UDI-DI (Unit of Use): 04046955127832; Lot Number: 0062013246. 16. REF: 552136: Product Code: CESK; UDI-DI (Primary): 04046955127863; UDI-DI (Unit of Use): 04046955127856; Lot Number: 0062003706. 17. REF: 552147: Product Code: CESK; UDI-DI (Primary): 04046955184071; UDI-DI (Unit of Use): 04046955186402; Lot Number: 0062017607. 18. REF: 552152: Product Code: CESK; UDI-DI (Primary): 04046955214419; UDI-DI (Unit of Use): 04046955264407; Lot Number: 0062006313. 19. REF: 552153: Product Code: CESK; UDI-DI (Primary): 04046955214426; UDI-DI (Unit of Use): 04046955243037; Lot Number: 0062017625. 20. REF: 552174: Product Code: CESK; UDI-DI (Primary): 04046955589449; UDI-DI (Unit of Use): 04046955589432; Lot Number: 0062006317. 21. REF: 552176: Product Code: CESK; UDI-DI (Primary): 04046955589487; UDI-DI (Unit of Use): 04046955589470; Lot Number: 0061983245. 22. REF: 552177: Product Code: CESK; UDI-DI (Primary): 04046955596102; UDI-DI (Unit of Use): 04046955596096; Lot Number: 0062014364. 23. REF: 552179: Product Code: CESK; UDI-DI (Primary): 04046955596140; UDI-DI (Unit of Use): 04046955596133; Lot Number: 0062013260. 24. REF: 552180: Product Code: CESK; UDI-DI (Primary): 04046955596164; UDI-DI (Unit of Use): 04046955596157; Lot Number: 0062000125. 25. REF: 552192: Product Code: CESK; UDI-DI (Primary): 04046955701063; UDI-DI (Unit of Use): 04046955701056; Lot Number: 0062005198. 26. REF: 552197: Product Code: CESK; UDI-DI (Primary): 04046955862498; UDI-DI (Unit of Use): 04046955862481; Lot Number: 0062017634. 27. REF: 555098: Product Code: CESK; UDI-DI (Primary): 04046964313578; UDI-DI (Unit of Use): 04046964313554; Lot Number: 0062006293. 28. REF: 555422: Product Code: CESK; UDI-DI (Primary): 04046964315534; UDI-DI (Unit of Use): 04046964315503; Lot Number: 0062019003. 29. REF: 555450: Product Code: CESK; UDI-DI (Primary): 04046964315831; UDI-DI (Unit of Use): 04046964315817; Lot Number: 0062016181. 30. REF: 555484: Product Code: CESK; UDI-DI (Primary): 04046964315954; UDI-DI (Unit of Use): 04046964315930; Lot Number: 0062012043. Expiration Date: 07/31/2026.5,770 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product code CE17TKFC and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 39 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Sep 18, 202512. FDA classified it Class II: Oct 9, 202523. Published in FDA’s Enforcement Report: Oct 15, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a potential issue with the lid position, so it's recommended to check if your unit is affected before use.

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Where this comes from

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-0116-2026 (September 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0116-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA