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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

Stradis Medical, LLC dba Stradis Healthcare: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Agency Publication Date: December 14, 2022
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Affected Products

Product: HENRY SCHEIN, Basin Pack, Item No.570-1692

UDI/DI (case) H65857016921, UDI/DI (kit)M75257016920, Serial/Lot Numbers: 22257490755

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Basin Set, Item No.570-1803

UDI/DI (case) H65857018031, UDI/DI (kit)M75257018030, Serial/Lot Numbers: 22258490734

Lot Numbers:
Numbers
Product: HENRY SCHEIN, BREAST PACK, Item No.570-2397

UDI/DI (case) H65857023971, UDI/DI (kit)M75257023970, Serial/Lot Numbers: 22235489451

Lot Numbers:
Numbers
Product: HENRY SCHEIN, GYN PACK, Item No.570-2625

UDI/DI (case) H65857026251, UDI/DI (kit)M75257026250, Serial/Lot Numbers: 22230491067

Lot Numbers:
Numbers
Product: HENRY SCHEIN, ENT PACK, Item No.570-2718

UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582, 22256491864

Lot Numbers:
Numbers
Product: HENRY 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: 22242489582

Lot Numbers:
Numbers
Product: HENRY SCHEIN, VEIN TRAY, Item No.570-2738,

UDI/DI (case) H65857027381, UDI/DI (kit)M75257027380, Serial/Lot Numbers: 22257490591

Lot Numbers:
Numbers
Product: HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742

UDI/DI (case) H65857027421, UDI/DI (kit)M75257027420, Serial/Lot Numbers: 22252489778

Lot Numbers:
Numbers
Product: HENRY SCHEIN, OMFS, Item No.570-2779,

UDI/DI (case) H65857027791, UDI/DI (kit)M75257027790, Serial/Lot Numbers: 22262489585, 22270490757

Lot Numbers:
Numbers
Product: HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,

UDI/DI (case) H65857027831, UDI/DI (kit)M75257027830, Serial/Lot Numbers: 22234489305

Lot Numbers:
Numbers
Product: HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787

UDI/DI (case) H65857027871, UDI/DI (kit)M75257027870, Serial/Lot Numbers: 22262491981

Lot Numbers:
Numbers
Product: HENRY SCHEIN, CATH PACK Item No.570-2789

UDI/DI (case) H65857027891, UDI/DI (kit)M75257027890, Serial/Lot Numbers: 22252491561

Lot Numbers:
Numbers
Product: HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793

UDI/DI (case) H65857027931, UDI/DI (kit)M75257027930, Serial/Lot Numbers: 22241489575

Lot Numbers:
Numbers
Product: HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883

UDI/DI (case) H65857028831, UDI/DI (kit)M75257028831, Serial/Lot Numbers: 22229489323

Lot Numbers:
Numbers
Product: HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

UDI/DI (case) H65857028901, UDI/DI (kit)M75257028900, Serial/Lot Numbers: 22262492001

Lot Numbers:
Numbers
Product: HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813

Lot Numbers:
Numbers
Product: HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,

UDI/DI (case) H65857029001, UDI/DI (kit)M75257029000, Serial/Lot Numbers: 22252489760

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Knee Pack, Item No.570-2908,

UDI/DI (case) H65857029081, UDI/DI (kit)M75257029080, Serial/Lot Numbers: 22241489773

Lot Numbers:
Numbers
Product: HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930

UDI/DI (case) H65857029301, UDI/DI (kit)M75257029300, Serial/Lot Numbers: 22235490920

Lot Numbers:
Numbers
Product: HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

UDI/DI (case) H65857029461, UDI/DI (kit)M75257029460, Serial/Lot Numbers: 22242490745

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Amnio Tray, Item No.570-3059,

UDI/DI (case) H65857030591, UDI/DI (kit)M75257030590, Serial/Lot Numbers: 22257487536

Lot Numbers:
Numbers
Product: HENRY SCHEIN, RHINO PACK, Item No.570-3070

UDI/DI (case) H65857030701, UDI/DI (kit)M75257030700, Serial/Lot Numbers: 22235491255, 22241491256

Lot Numbers:
Numbers
Product: HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072

UDI/DI (case) H65857030721, UDI/DI (kit)M75257030720, Serial/Lot Numbers: 22241490953

Lot Numbers:
Numbers
Product: HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089

UDI/DI (case) H65857030891, UDI/DI (kit)M75257030890, Serial/Lot Numbers: 22251491690

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,

UDI/DI (case) H65857030911, UDI/DI (kit)M75257030910, Serial/Lot Numbers: 22258490762

Lot Numbers:
Numbers
Product: HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092

UDI/DI (case) H65857030921, UDI/DI (kit)M75257030920, Serial/Lot Numbers: 22231491193

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Labiaplasty PackItem No.570-3118,

UDI/DI (case) H65857031181, UDI/DI (kit)M75257031180, Serial/Lot Numbers: 22234491292

Lot Numbers:
Numbers
Product: HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131

UDI/DI (case) H65857031311, UDI/DI (kit)M75257031310, Serial/Lot Numbers: 22257490596

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

UDI/DI (case) M75260060GCTS1, UDI/DI (kit)M75260060GCTS0, Serial/Lot Numbers: 22257490438

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Lipo, Item No.681-254,

UDI/DI (case) M7526812541, UDI/DI (kit)M7526812540, Serial/Lot Numbers: 22270492010

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

UDI/DI (case) M7526820011, UDI/DI (kit)M7526820010, Serial/Lot Numbers: 22236489633

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,

UDI/DI (case) M7268212281, UDI/DI (kit)M7268212280, Serial/Lot Numbers: 22237491041

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,

UDI/DI (case) M7526821301, UDI/DI (kit)M7526821300, Serial/Lot Numbers: 22237491040

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Phleb, Item No.682-1425,

UDI/DI (case) M75268214251, UDI/DI (kit)M75268214250, Serial/Lot Numbers: 22236490624

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,

UDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,

UDI/DI (case) M75268217281, UDI/DI (kit)M75268217280, Serial/Lot Numbers: 22235489419

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Vein, Item No.682-1732,

UDI/DI (case) M75268217321, UDI/DI (kit)M75268217320, Serial/Lot Numbers: 22230489185

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,

UDI/DI (case) M7526821942NL11, UDI/DI (kit)M7526821942NL10, Serial/Lot Numbers: 22251491808

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,

UDI/DI (case) M7526821993R11, UDI/DI (kit)M7526821993R10, Serial/Lot Numbers: 22235491208

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Medical Vein, Item No.682-330,

UDI/DI (case) M7526823301, UDI/DI (kit)M7526823300, Serial/Lot Numbers: 22238490518

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

UDI/DI (case) M752682334R11, UDI/DI (kit)M752682334R10, Serial/Lot Numbers: 22231489619

Lot Numbers:
Numbers
Product: www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,

UDI/DI (case) M7526824941, UDI/DI (kit)M7526824940, Serial/Lot Numbers: 22234489198

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 22256490827

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Vein, Item No.682-577,

UDI/DI (case) M7526825771, UDI/DI (kit)M7526585770, Serial/Lot Numbers: 22230490618

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,

UDI/DI (case) M7526829471, UDI/DI (kit)M7526829470, Serial/Lot Numbers: 22236491032

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,

UDI/DI (case) M7526861421, UDI/DI (kit)M7526861420, Serial/Lot Numbers: 22236491028

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Angio Pack, Item No.686-199,

UDI/DI (case) M7526861991, UDI/DI (kit)M7526861990, Serial/Lot Numbers: 22236491017

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Breast, Item No.693-276,

UDI/DI (case) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 22242490001

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Vas Pack, Item No.888-2520,

UDI/DI (case) H65888825201, UDI/DI (kit)M75288825200, Serial/Lot Numbers: 22256490684

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,

UDI/DI (case) H65888825491, UDI/DI (kit)M75288825490, Serial/Lot Numbers: 22230489459

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,

UDI/DI (case) M752SS0772251, UDI/DI (kit)M752SS0772251, Serial/Lot Numbers: 22255490439

Lot Numbers:
Numbers
Product: STRADIS 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, 22255491484

Lot Numbers:
Numbers
Numbers
Product: ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray

UDI/DI (case) M75200338800, UDI/DI (kit)M75200338800, Serial/Lot Numbers: 22242490999

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS

UDI/DI (case) M75220177RPSS1, UDI/DI (kit)M75220177RPSS0, Serial/Lot Numbers: 22263491083

Lot Numbers:
Numbers
Product: BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray

UDI/DI (case) M75240310SBI1, UDI/DI (kit)M75240310SBI0, Serial/Lot Numbers: 22241489853

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental

UDI/DI (case) M75240450SMS1, UDI/DI (kit)M75240450SMS0, Serial/Lot Numbers: 22262490676

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray

UDI/DI (case) M75240510TWS1, UDI/DI (kit)M75240510TWS0, Serial/Lot Numbers: 22236490637

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

UDI/DI (case) M75240551TMS1, UDI/DI (kit)M75240551TMS0, Serial/Lot Numbers: 22230489112

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental

UDI/DI (case) M75240649ECS1, UDI/DI (kit)M75240649ECS0, Serial/Lot Numbers: 22270491425

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray

UDI/DI (case) M75240714IES1, UDI/DI (kit)M75240714IES0, Serial/Lot Numbers: 22229490633, 22229490633, 22229490633

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray

UDI/DI (case) M75240788SMS1, UDI/DI (kit)M75240788SMS0, Serial/Lot Numbers: 22234489435

Lot Numbers:
Numbers
Product: Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray

UDI/DI (case) M75240996WLS1, UDI/DI (kit)M75240996WLS0, Serial/Lot Numbers: 22230489371

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray

UDI/DI (case) M75241015NSI1, UDI/DI (kit)M75241015NSI0, Serial/Lot Numbers: 22230491043

Lot Numbers:
Numbers
Product: Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

UDI/DI (case) M7524111UTI0, UDI/DI (kit)M7524111UTI0, Serial/Lot Numbers: 22229491074

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,

UDI/DI (case) M75241137TDS1, UDI/DI (kit)M75241137TDS0, Serial/Lot Numbers: 22230489097

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental

UDI/DI (case) M75241213ATCP1, UDI/DI (kit)M75241213ATCP0, Serial/Lot Numbers: 22262491452

Lot Numbers:
Numbers
Product: Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP

UDI/DI (case) M75241236SDSP1, UDI/DI (kit)M75241236SDSP0, Serial/Lot Numbers: 22235489632

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,

UDI/DI (case) M7525050101, UDI/DI (kit)M7525050100, Serial/Lot Numbers: 22269491064,

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001

UDI/DI (case) M7525150011, UDI/DI (kit)M7525150011, Serial/Lot Numbers: 22258491483

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular

UDI/DI (case) M7525250381, UDI/DI (kit)M7525250380, Serial/Lot Numbers: 22251491752,

Lot Numbers:
Numbers
Product: STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray

UDI/DI (case) M7525250711, UDI/DI (kit)M7525250710, Serial/Lot Numbers: 22252491061

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611

UDI/DI (case) H65857006111, UDI/DI (kit)M75257006110, Serial/Lot Numbers: 22257490683

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Vein Clinics 1, Item No.570-1426

UDI/DI (case) H65857014261, UDI/DI (kit)M75257014260, Serial/Lot Numbers: 22257490682

Lot Numbers:
Numbers
Product: HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

UDI/DI (case) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 22230491082

Lot Numbers:
Numbers
Product: HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482

UDI/DI (case) M75257014821, UDI/DI (kit)M75257014820, Serial/Lot Numbers: 22235489736

Lot Numbers:
Numbers
Product: HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

UDI/DI (case) H65857015081, UDI/DI (kit)M75257015080, Serial/Lot Numbers: 22252490204

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91124
Status: Active
Manufacturer: Stradis Medical, LLC dba Stradis Healthcare
Manufactured In: United States
Units Affected: 78 products (80 kits; 10 kits; 25 units; 80 units; 12 units; 18 units; 6 units; 20 units; 6 units; 18 units; 6 units; 180 units; 30 units; 162 units; 20 units; 12 units; 20 units; 100 units; 100 units; 180 units; 150 units; 10 units; 800 units; 15 units; 20 units; 35 units; 30 units; 96 units; 8 units; 20 units; 104 units; 24 units; 18 units; 12 units; 90 units; 5 units; 675 units; 100 units; 18 units; 24 units; 25 units; 144 units; 10 units; 48 units; 16 units; 144 units; 510 units; 328 units; 27 units; 80 units; 72 units; 581 units; 42 units; 140 units; 300 units; 6 units; 15 units; 5 units; 40 units; 20 units; 20 units; 40 units; 10 units; 100 units; 400 units; 30 units; 40 units; 10 units; 10 units; 25 units; 15 units; 105 units; 10; 24 units; 16 units; 304 units; 3 units; 75 units)

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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 · 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.