Class II FDA device recall · Z-2086-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292

Why it was recalled

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers:  59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383;   b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers:  58714313;   c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128  (unit), Lot Numbers:  58746278;   d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers:  58745371;   e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers:  58774885, 58774885;   f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers:  58800174;   g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers:  58762104;   h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers:  58810330;   i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit), , Lot Numbers:  58698974;   j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit), , Lot Numbers:  58698907;   k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit), , Lot Numbers:  58777761;   l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit), , Lot Numbers:  58811834;   m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers:  58737081;   n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers:  58698042;   o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers:  58736862;   p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers:  58823595;   q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit), , Lot Numbers:  58697963;   r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers:  58789411;   s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit), , Lot Numbers:  58808416;   t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit), , Lot Numbers 58789260;    u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit), , Lot Numbers:  58738315  v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit), , Lot Numbers:  58701598

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: DeRoyal Industries Inc
Product type: Devices
Recall number: Z-2086-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Powell, TN
Recall initiated: 2023-05-30

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2086-2023 · Source: openFDA enforcement.