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Lower risk Medical device recall · FDA · Published November 2, 2022

Stradis Healthcare Vas Reversal Pack Recall: Risk of Sterility Breach

Stradis Healthcare recalls Vas Reversal Pack (Item 888-2549) due to potential sterility breaches from incomplete bag sealing. Affected units have specific serial numbers and were sold through Henry Schein.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0557-2023Medical deviceStradis Healthcare ›
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Contact the company

Recalling firmStradis Medical, LLC dba Stradis Healthcare3025 Northwoods Pkwy · Peachtree Corners, GA 30071-1524
✎ GovInfoNow plain-language explainer

Stradis Healthcare is recalling its Vas Reversal Pack (Item 888-2549) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, posing a risk during medical procedures. Read more at govinfonow.com/recall/59656-stradis-healthcare-vas-reversal-pack-recall-risk-of-sterility-breach.

Source Summary by GovInfoNow · govinfonow.com/recall/59656-stradis-healthcare-vas-reversal-pack-recall-risk-of-sterility-breach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0557-2023

Cite this page

“Stradis Healthcare Vas Reversal Pack Recall: Risk of Sterility Breach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59656-stradis-healthcare-vas-reversal-pack-recall-risk-of-sterility-breach. Based on FDA recall #Z-0557-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2023%22&limit=1).

Stradis Medical, LLC dba Stradis Healthcare is recalling the HENRY SCHEIN Vas Reversal Pack due to sterility risks. The Food and Drug Administration announced the Class II recall on November 2, 2022.

How to tell if you have it

  • Brand: Stradis Healthcare
  • Product: HENRY SCHEIN, Vas Reversal Pack
  • Item No.: 888-2549
  • UDI/DI (case): H65888825491
  • UDI/DI (kit): M75288825490
  • Lot Number: 22230489459

The hazard

The medical and surgical procedure trays and kits underwent manufacturing conditions that may result in the outer bag being incompletely sealed. This defect may result in a breach in the sterility of the kit.

Context

GovInfoNow's records show Stradis Medical, LLC dba Stradis Healthcare has had four other recalls since September 10, 2021. Other recent recalls of similar products include AVID Medical Halyard Transport Bag Kit Recall (January 2, 2026), Medline Surgical Packs Recall (January 7, 2026), and Boston Scientific EndoVive Safety PEG Kit Recall (February 10, 2026).

How to tell if you have this one

Check for the item number 888-2549 on the Vas Reversal Pack. Affected units have serial numbers starting with 22230489459 and were sold through Henry Schein.

  • Brand
    Stradis Healthcare
  • Category
    Medical device
FDA recall event · 78 products

All 78 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
    US nationwide distribution, and Canada.
Recall numberProduct, codes & lotsQuantity
Z-0481-2023STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431; a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 2225549148480 kits
Z-0482-2023ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray; UDI/DI (case) M75200338800, UDI/DI (kit)M75200338800, Serial/Lot Numbers: 2224249099910 kits
Z-0483-2023STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS; UDI/DI (case) M75220177RPSS1, UDI/DI (kit)M75220177RPSS0, Serial/Lot Numbers: 2226349108325 units
Z-0484-2023BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray; UDI/DI (case) M75240310SBI1, UDI/DI (kit)M75240310SBI0, Serial/Lot Numbers: 2224148985380 units
Z-0485-2023STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental; UDI/DI (case) M75240450SMS1, UDI/DI (kit)M75240450SMS0, Serial/Lot Numbers: 2226249067612 units
Z-0486-2023STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray; UDI/DI (case) M75240510TWS1, UDI/DI (kit)M75240510TWS0, Serial/Lot Numbers: 2223649063718 units
Z-0487-2023STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray; UDI/DI (case) M75240551TMS1, UDI/DI (kit)M75240551TMS0, Serial/Lot Numbers: 222304891126 units
Z-0488-2023STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray; UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 2224249151620 units
Z-0489-2023STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental; UDI/DI (case) M75240649ECS1, UDI/DI (kit)M75240649ECS0, Serial/Lot Numbers: 222704914256 units
Z-0490-2023STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray; UDI/DI (case) M75240714IES1, UDI/DI (kit)M75240714IES0, Serial/Lot Numbers: 22229490633, 22229490633, 2222949063318 units
Z-0491-2023STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray; UDI/DI (case) M75240788SMS1, UDI/DI (kit)M75240788SMS0, Serial/Lot Numbers: 222344894356 units
Z-0492-2023Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray; UDI/DI (case) M75240996WLS1, UDI/DI (kit)M75240996WLS0, Serial/Lot Numbers: 22230489371180 units
Z-0493-2023STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray; UDI/DI (case) M75241015NSI1, UDI/DI (kit)M75241015NSI0, Serial/Lot Numbers: 2223049104330 units
Z-0494-2023Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray; UDI/DI (case) M7524111UTI0, UDI/DI (kit)M7524111UTI0, Serial/Lot Numbers: 22229491074162 units
Z-0495-2023STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,; UDI/DI (case) M75241137TDS1, UDI/DI (kit)M75241137TDS0, Serial/Lot Numbers: 2223048909720 units
Z-0496-2023STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental; UDI/DI (case) M75241213ATCP1, UDI/DI (kit)M75241213ATCP0, Serial/Lot Numbers: 2226249145212 units
Z-0497-2023Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP; UDI/DI (case) M75241236SDSP1, UDI/DI (kit)M75241236SDSP0, Serial/Lot Numbers: 2223548963220 units
Z-0498-2023STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,; UDI/DI (case) M7525050101, UDI/DI (kit)M7525050100, Serial/Lot Numbers: 22269491064,100 units
Z-0499-2023STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001; UDI/DI (case) M7525150011, UDI/DI (kit)M7525150011, Serial/Lot Numbers: 22258491483100 units
Z-0500-2023STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular; UDI/DI (case) M7525250381, UDI/DI (kit)M7525250380, Serial/Lot Numbers: 22251491752,180 units
Z-0501-2023STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray; UDI/DI (case) M7525250711, UDI/DI (kit)M7525250710, Serial/Lot Numbers: 22252491061150 units
Z-0502-2023HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611; UDI/DI (case) H65857006111, UDI/DI (kit)M75257006110, Serial/Lot Numbers: 2225749068310 units
Z-0503-2023HENRY SCHEIN, Vein Clinics 1, Item No.570-1426; UDI/DI (case) H65857014261, UDI/DI (kit)M75257014260, Serial/Lot Numbers: 22257490682800 units
Z-0504-2023HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray; UDI/DI (case) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 2223049108215 units
Z-0505-2023HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482; UDI/DI (case) M75257014821, UDI/DI (kit)M75257014820, Serial/Lot Numbers: 2223548973620 units
Z-0506-2023HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray; UDI/DI (case) H65857015081, UDI/DI (kit)M75257015080, Serial/Lot Numbers: 2225249020435 units
Z-0507-2023HENRY SCHEIN, Basin Pack, Item No.570-1692; UDI/DI (case) H65857016921, UDI/DI (kit)M75257016920, Serial/Lot Numbers: 2225749075530 units
Z-0508-2023HENRY SCHEIN, Basin Set, Item No.570-1803; UDI/DI (case) H65857018031, UDI/DI (kit)M75257018030, Serial/Lot Numbers: 2225849073496 units
Z-0509-2023HENRY SCHEIN, BREAST PACK, Item No.570-2397; UDI/DI (case) H65857023971, UDI/DI (kit)M75257023970, Serial/Lot Numbers: 222354894518 units
Z-0510-2023HENRY SCHEIN, GYN PACK, Item No.570-2625; UDI/DI (case) H65857026251, UDI/DI (kit)M75257026250, Serial/Lot Numbers: 2223049106720 units
Z-0511-2023HENRY SCHEIN, ENT PACK, Item No.570-2718; UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582, 22256491864104 units
Z-0512-2023HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505; UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 2224248958224 units
Z-0513-2023HENRY SCHEIN, VEIN TRAY, Item No.570-2738,; UDI/DI (case) H65857027381, UDI/DI (kit)M75257027380, Serial/Lot Numbers: 2225749059118 units
Z-0514-2023HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742; UDI/DI (case) H65857027421, UDI/DI (kit)M75257027420, Serial/Lot Numbers: 2225248977812 units
Z-0515-2023HENRY SCHEIN, OMFS, Item No.570-2779,; UDI/DI (case) H65857027791, UDI/DI (kit)M75257027790, Serial/Lot Numbers: 22262489585, 2227049075790 units
Z-0516-2023HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,; UDI/DI (case) H65857027831, UDI/DI (kit)M75257027830, Serial/Lot Numbers: 222344893055 units
Z-0517-2023HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787; UDI/DI (case) H65857027871, UDI/DI (kit)M75257027870, Serial/Lot Numbers: 22262491981675 units
Z-0518-2023HENRY SCHEIN, CATH PACK Item No.570-2789; UDI/DI (case) H65857027891, UDI/DI (kit)M75257027890, Serial/Lot Numbers: 22252491561100 units
Z-0519-2023HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793; UDI/DI (case) H65857027931, UDI/DI (kit)M75257027930, Serial/Lot Numbers: 2224148957518 units
Z-0520-2023HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883; UDI/DI (case) H65857028831, UDI/DI (kit)M75257028831, Serial/Lot Numbers: 2222948932324 units
Z-0521-2023HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890; UDI/DI (case) H65857028901, UDI/DI (kit)M75257028900, Serial/Lot Numbers: 2226249200125 units
Z-0522-2023HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891; UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813144 units
Z-0523-2023HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,; UDI/DI (case) H65857029001, UDI/DI (kit)M75257029000, Serial/Lot Numbers: 2225248976010 units
Z-0524-2023HENRY SCHEIN, Knee Pack, Item No.570-2908,; UDI/DI (case) H65857029081, UDI/DI (kit)M75257029080, Serial/Lot Numbers: 2224148977348 units
Z-0525-2023HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930; UDI/DI (case) H65857029301, UDI/DI (kit)M75257029300, Serial/Lot Numbers: 2223549092016 units
Z-0526-2023HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946; UDI/DI (case) H65857029461, UDI/DI (kit)M75257029460, Serial/Lot Numbers: 22242490745144 units
Z-0527-2023HENRY SCHEIN, Amnio Tray, Item No.570-3059,; UDI/DI (case) H65857030591, UDI/DI (kit)M75257030590, Serial/Lot Numbers: 22257487536510 units
Z-0528-2023HENRY SCHEIN, RHINO PACK, Item No.570-3070; UDI/DI (case) H65857030701, UDI/DI (kit)M75257030700, Serial/Lot Numbers: 22235491255, 22241491256328 units
Z-0529-2023HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072; UDI/DI (case) H65857030721, UDI/DI (kit)M75257030720, Serial/Lot Numbers: 2224149095327 units
Z-0530-2023HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089; UDI/DI (case) H65857030891, UDI/DI (kit)M75257030890, Serial/Lot Numbers: 2225149169080 units
Z-0531-2023HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,; UDI/DI (case) H65857030911, UDI/DI (kit)M75257030910, Serial/Lot Numbers: 2225849076272 units
Z-0532-2023HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092; UDI/DI (case) H65857030921, UDI/DI (kit)M75257030920, Serial/Lot Numbers: 22231491193581 units
Z-0533-2023HENRY SCHEIN, Labiaplasty PackItem No.570-3118,; UDI/DI (case) H65857031181, UDI/DI (kit)M75257031180, Serial/Lot Numbers: 2223449129242 units
Z-0534-2023HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131; UDI/DI (case) H65857031311, UDI/DI (kit)M75257031310, Serial/Lot Numbers: 22257490596140 units
Z-0535-2023STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,; UDI/DI (case) M75260060GCTS1, UDI/DI (kit)M75260060GCTS0, Serial/Lot Numbers: 22257490438300 units
Z-0536-2023STRADIS HEALTHCARE, Lipo, Item No.681-254,; UDI/DI (case) M7526812541, UDI/DI (kit)M7526812540, Serial/Lot Numbers: 222704920106 units
Z-0537-2023STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,; UDI/DI (case) M7526820011, UDI/DI (kit)M7526820010, Serial/Lot Numbers: 2223648963315 units
Z-0538-2023STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,; UDI/DI (case) M7268212281, UDI/DI (kit)M7268212280, Serial/Lot Numbers: 222374910415 units
Z-0539-2023STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,; UDI/DI (case) M7526821301, UDI/DI (kit)M7526821300, Serial/Lot Numbers: 2223749104040 units
Z-0540-2023STRADIS HEALTHCARE, Phleb, Item No.682-1425,; UDI/DI (case) M75268214251, UDI/DI (kit)M75268214250, Serial/Lot Numbers: 2223649062420 units
Z-0541-2023STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,; UDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 2223749103820 units
Z-0542-2023STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,; UDI/DI (case) M75268217281, UDI/DI (kit)M75268217280, Serial/Lot Numbers: 2223548941940 units
Z-0543-2023STRADIS HEALTHCARE, Vein, Item No.682-1732,; UDI/DI (case) M75268217321, UDI/DI (kit)M75268217320, Serial/Lot Numbers: 2223048918510 units
Z-0544-2023STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,; UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509100 units
Z-0545-2023STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,; UDI/DI (case) M7526821942NL11, UDI/DI (kit)M7526821942NL10, Serial/Lot Numbers: 22251491808400 units
Z-0546-2023STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,; UDI/DI (case) M7526821993R11, UDI/DI (kit)M7526821993R10, Serial/Lot Numbers: 2223549120830 units
Z-0547-2023STRADIS HEALTHCARE, Medical Vein, Item No.682-330,; UDI/DI (case) M7526823301, UDI/DI (kit)M7526823300, Serial/Lot Numbers: 2223849051840 units
Z-0548-2023STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,; UDI/DI (case) M752682334R11, UDI/DI (kit)M752682334R10, Serial/Lot Numbers: 2223148961910 units
Z-0549-2023www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,; UDI/DI (case) M7526824941, UDI/DI (kit)M7526824940, Serial/Lot Numbers: 2223448919810 units
Z-0550-2023STRADIS HEALTHCARE, Endo Pack, Item No.682-509,; UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 2225649082725 units
Z-0551-2023STRADIS HEALTHCARE, Vein, Item No.682-577,; UDI/DI (case) M7526825771, UDI/DI (kit)M7526585770, Serial/Lot Numbers: 2223049061815 units
Z-0552-2023STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,; UDI/DI (case) M7526829471, UDI/DI (kit)M7526829470, Serial/Lot Numbers: 22236491032105 units
Z-0553-2023STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,; UDI/DI (case) M7526861421, UDI/DI (kit)M7526861420, Serial/Lot Numbers: 2223649102810
Z-0554-2023STRADIS HEALTHCARE, Angio Pack, Item No.686-199,; UDI/DI (case) M7526861991, UDI/DI (kit)M7526861990, Serial/Lot Numbers: 2223649101724 units
Z-0555-2023STRADIS HEALTHCARE, Breast, Item No.693-276,; UDI/DI (case) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 2224249000116 units
Z-0556-2023HENRY SCHEIN, Vas Pack, Item No.888-2520,; UDI/DI (case) H65888825201, UDI/DI (kit)M75288825200, Serial/Lot Numbers: 22256490684304 units
Z-0557-2023HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,; UDI/DI (case) H65888825491, UDI/DI (kit)M75288825490, Serial/Lot Numbers: 222304894593 units
Z-0558-2023STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,; UDI/DI (case) M752SS0772251, UDI/DI (kit)M752SS0772251, Serial/Lot Numbers: 2225549043975 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the item number (888-2549) and serial numbers (starting with 22230489459) on the Vas Reversal Pack.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US nationwide distribution, and Canada.” 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 49 days after the firm started it.

1. Firm started the recall: Nov 2, 202212. FDA classified it Class II: Dec 14, 202223. Published in FDA’s Enforcement Report: Dec 21, 202232022
  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

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for potential sterility breaches, but the risk is low as the issue is related to manufacturing, not immediate harm.

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Keep exploring

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-0557-2023 (November 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0557-2023 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.
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