Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T
Medical device recall Z-3045-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.
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 Sep 18, 2024. Copied from openFDA on Oct 20, 2026.
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?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDS984187T , Lot Number 22JBX647 ; CDS984187T , Lot Number 22KBH092 ; CDS984187T , Lot Number 22KBN639 ; CDS984187T , Lot Number 23ABJ847 ; CDS984187T , Lot Number 23DBN636 ; CDS984187T , Lot Number 23EBN741 ; CDS984187T , Lot Number…
Every code shown here, 1,997 characters
CDS984187T , Lot Number 22JBX647 ; CDS984187T , Lot Number 22KBH092 ; CDS984187T , Lot Number 22KBN639 ; CDS984187T , Lot Number 23ABJ847 ; CDS984187T , Lot Number 23DBN636 ; CDS984187T , Lot Number 23EBN741 ; CDS984187T , Lot Number 23FBO660 ; CDS984187U , Lot Number 23GBV733 ; CDS984187U , Lot Number 23HBA604 ; CDS984187U , Lot Number 23JBE143 ; CDS984187U , Lot Number 23JBE436 ; CDS984187U , Lot Number 23JBX523 ; CDS984187U , Lot Number 23LBN764 ; CDS984187U , Lot Number 24BBN238 ; CDS984187U , Lot Number 24BBU609 ; DYNDA1567D, Lot Number 2019071090; DYNDA1977A, Lot Number 2019071090; DYNDH1453, Lot Number 2019071090; DYNDL1569A, Lot Number 2019071090; DYNJ0157511K , Lot Number 23LMI154 ; DYNJ0161619I , Lot Number 23EMI816 ; DYNJ0161619I , Lot Number 23FMC245 ; DYNJ0161619I , Lot Number 23FMI370 ; DYNJ0161619I , Lot Number 23HMB229 ; DYNJ0161619I , Lot Number 23KMC793 ; DYNJ0161619I , Lot Number 23KMF807 ; DYNJ0477038K , Lot Number 23CBW969 ; DYNJ0477038K , Lot Number 23EBW988 ; DYNJ0477038K , Lot Number 23HBA845 ; DYNJ0477038K , Lot Number 23IBP147 ; DYNJ0477038K , Lot Number 23LBE881 ; DYNJ0531985R , Lot Number 22HMF853 ; DYNJ0531985R , Lot Number 22LMG691 ; DYNJ0531985R , Lot Number 23AMF501 ; DYNJ0531985R , Lot Number 23CMA603 ; DYNJ0531985R , Lot Number 23DMG508 ; DYNJ0537705L , Lot Number 23FMG696 ; DYNJ0537705L , Lot Number 23IMC689 ; DYNJ0780009W , Lot Number 22HMF696 ; DYNJ0780009W , Lot Number 22JME002 ; DYNJ0780009Y , Lot Number 23EMB610 ; DYNJ0780009Y , Lot Number 23EMI825 ; DYNJ0780009Y , Lot Number 23FMA234 ; DYNJ0780009Y , Lot Number 23HMC653 ; DYNJ0780009Y , Lot Number 23JMB180 ; DYNJ0780009Y , Lot Number 23JMI648 ; DYNJ0843760I , Lot Number 23DDA645 ; DYNJ0843760I , Lot Number 23EDA680 ; DYNJ0843760J , Lot Number 23JDA821 ; DYNJ40099B , Lot Number 22ABP008 ; DYNJ40099B , Lot Number 22BBW136 ; DYNJ40099C , Lot Number 22FMB339 ; DYNJ40099C , Lot Number 22HMA727 ; DYNJ40099C , Lot Number 22IMG228 ; DYNJ40099C , Lot Number 23BMG958 ; DYNJ40099C ,…
FDA’s list runs to 7,050 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.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Apr 8, 2024.
- FDA classified it on Sep 6, 2024.
- FDA’s Enforcement Report published it on Sep 18, 2024.
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.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 7,050 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.