thejoe Stradis Medical, LLC dba Stradis Healt

Stradis Medical, LLC dba Stradis Healthcare: 93 FDA recall reports

Every medical device recall the FDA has published for Stradis Medical, LLC dba Stradis Healthcare. The fault, and how the agency graded it.

93Reports

0Class I

92Ongoing

2022-12-21Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	93

By year reported

Year	Reports
2021	7
2022	86

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,

Z-0557-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Where it went: US nationwide distribution, and Canada.
How much: 3 units

STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

Z-0544-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Where it went: US nationwide distribution, and Canada.
How much: 100 units

STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray

Z-0490-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 18 units

HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089

Z-0530-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Where it went: US nationwide distribution, and Canada.
How much: 80 units

STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,

Z-0546-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Where it went: US nationwide distribution, and Canada.
How much: 30 units

HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482

Z-0505-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Where it went: US nationwide distribution, and Canada.
How much: 20 units

HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

Z-0522-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Where it went: US nationwide distribution, and Canada.
How much: 144 units

STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,

Z-0542-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
Where it went: US nationwide distribution, and Canada.
How much: 40 units

HENRY SCHEIN, Basin Set, Item No.570-1803

Z-0508-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, Basin Set, Item No.570-1803
Where it went: US nationwide distribution, and Canada.
How much: 96 units

HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot N

Z-0512-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Where it went: US nationwide distribution, and Canada.
How much: 24 units

HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

Z-0504-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 15 units

HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787

Z-0517-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Where it went: US nationwide distribution, and Canada.
How much: 675 units

STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

Z-0535-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
Where it went: US nationwide distribution, and Canada.
How much: 300 units

HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

Z-0506-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 35 units

HENRY SCHEIN, Vas Pack, Item No.888-2520,

Z-0556-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, Vas Pack, Item No.888-2520,
Where it went: US nationwide distribution, and Canada.
How much: 304 units

STRADIS HEALTHCARE, Phleb, Item No.682-1425,

Z-0540-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Phleb, Item No.682-1425,
Where it went: US nationwide distribution, and Canada.
How much: 20 units

HENRY SCHEIN, Labiaplasty PackItem No.570-3118,

Z-0533-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
Where it went: US nationwide distribution, and Canada.
How much: 42 units

HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793

Z-0519-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Where it went: US nationwide distribution, and Canada.
How much: 18 units

Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

Z-0494-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 162 units

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Z-0488-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 20 units

STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental

Z-0485-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
Where it went: US nationwide distribution, and Canada.
How much: 12 units

HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,

Z-0516-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
Where it went: US nationwide distribution, and Canada.
How much: 5 units

www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,

Z-0549-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
Where it went: US nationwide distribution, and Canada.
How much: 10 units

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

Z-0526-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
Where it went: US nationwide distribution, and Canada.
How much: 144 units

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

Z-0550-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Where it went: US nationwide distribution, and Canada.
How much: 25 units

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Z-0487-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Where it went: US nationwide distribution, and Canada.
How much: 6 units

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

Z-0521-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
Where it went: US nationwide distribution, and Canada.
How much: 25 units

STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

Z-0537-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Where it went: US nationwide distribution, and Canada.
How much: 15 units

HENRY SCHEIN, CATH PACK Item No.570-2789

Z-0518-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, CATH PACK Item No.570-2789
Where it went: US nationwide distribution, and Canada.
How much: 100 units

HENRY SCHEIN, OMFS, Item No.570-2779,

Z-0515-2023 · Class II · reported 2022-12-21 · Ongoing

Why it was recalled: 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.
Product: HENRY SCHEIN, OMFS, Item No.570-2779,
Where it went: US nationwide distribution, and Canada.
How much: 90 units

Showing the 30 most recent of 93. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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