Sterile Procedural Trays, labeled as the following: a
Medical device recall Z-1091-2023. 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
- 8,064 cases (12,425 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. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE’S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
8,064 cases (12,425 units), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982,…
Every code shown here, 1,991 characters
a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176; c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989; d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743; e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054; f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586; g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498; h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848; i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358; j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299; k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254; l. GYN LAPAROSCOPY CDS-LF, Item Number: CDS984536J, Case UDI/GTIN: 40193489831345, Unit UDI/GTIN: 10193489831344, Lot Number: 22IDB843; m. GYN LAPAROSCOPY CDS UCC-LF, Item Number: CDS984684D, Case UDI/GTIN: 40193489571364, Unit UDI/GTIN: 10193489571363, Lot Number: 22JBR850,22JBE881,22IBV318; n. DAY SURG GYN LAP CDS, Item Number: CDS984996K, Case UDI/GTIN: 40195327175772, Unit UDI/GTIN: 10195327175771, Lot Number: 22JBD508; o. GYN LAPAROSCOPY CDS, Item Number: CDS985217J, Case UDI/GTIN: 40195327110841, Unit…
FDA’s list runs to 17,682 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 17,682 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.