Sterile Procedural Trays, labeled as the following: a
Medical device recall Z-1079-2023. Published in FDA’s Enforcement Report on Feb 15, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 15, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 62,930 cases (215,456 units) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA
62,930 cases (215,456 units), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot…
Every code shown here, 1,998 characters
a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/GTIN: 10888277977495, Lot Number: 22IBE725; k. MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/GTIN: 10889942428540, Lot Number: 22JBU157,22JBB126; l. BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431, Unit UDI/GTIN: 10193489648430, Lot Number: 22JBP662,22JBO884; m. ROBOTIC PROCEDURE, Item Number: CDS982128O, Case UDI/GTIN: 40193489775533, Unit UDI/GTIN: 10193489775532, Lot Number: 22JBO084,22JBJ689; n. MAJOR VASCULAR CDS, Item Number: CDS982613G, Case UDI/GTIN: 40888277737076, Unit UDI/GTIN: 10888277737075, Lot Number: 22JBK713; o. PEDI LITHOTOMY, Item Number: CDS982718K, Case UDI/GTIN: 40193489418201, Unit UDI/GTIN: 10193489418200, Lot Number: 22JBR860,22JBK829,22IBH995; p. MAJOR CDS-1,…
FDA’s list runs to 107,986 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 17, 2022.
- FDA classified it on Feb 6, 2023.
- FDA’s Enforcement Report published it on Feb 15, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 107,986 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.