Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S
Medical device recall Z-2747-2024. Published in FDA’s Enforcement Report on Sep 4, 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 4, 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 procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165;…
Every code shown here, 1,992 characters
CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165; CDS982016T, Lot Numbers:22HBS644; CMPJ01846O, Lot Numbers:21LBQ988; CMPJ01846O, Lot Numbers:22FBV101; CMPJ05884J, Lot Numbers:21KBO037; CMPJ05884J, Lot Numbers:21KBU691; CMPJ05884J, Lot Numbers:21LBH778; CMPJ05884J, Lot Numbers:22IBG052; CMPJ05884J, Lot Numbers:22JBN865; CMPJ09860D, Lot Numbers:23KMB793; CMPJ09914C, Lot Numbers:23IDA209; CMPJ13389A, Lot Numbers:23CBL552; CMPJ13389B, Lot Numbers:23IBC818; CMPJ13389C, Lot Numbers:23KBU012; CMPJ13389C, Lot Numbers:23LBF106; CMPJ13389C, Lot Numbers:24ABD504; CMPJ13389C, Lot Numbers:24ABY610; CMPJ13389C, Lot Numbers:24BBV889; CMPJ13509, Lot Numbers:23IBF142; CMPJ21114O, Lot Numbers:23BBQ474; CMPJ21114O, Lot Numbers:23HBG033; CMPJ21114O, Lot Numbers:23IBV766; CMPJ21114O, Lot Numbers:23JBM292; CMPJ21114O, Lot Numbers:23KBK531; CMPJ21114O, Lot Numbers:21BBJ985; DYNJ0425965G, Lot Numbers:23GMH984; DYNJ0774664K, Lot Numbers:23HBP871; DYNJ40560B, Lot Numbers:23HBF219; DYNJ40560BH , Lot Numbers:23HBF219; DYNJ44134C, Lot Numbers:22JBQ075; DYNJ44134D, Lot Numbers:23BBK410; DYNJ44134D, Lot Numbers:23CBS145; DYNJ44134F, Lot Numbers:23EBC602; DYNJ44134F, Lot Numbers:23GBV482; DYNJ44134F, Lot Numbers:23JBP398; DYNJ44134F, Lot Numbers:23KBN024; DYNJ44134F, Lot Numbers:24ABC027; DYNJ45577A, Lot Numbers:21KBL221; DYNJ45577A, Lot Numbers:21KBT524; DYNJ48595, Lot Numbers:24BBO457; DYNJ49888I, Lot Numbers:22AMG372; DYNJ49888I, Lot Numbers:22KMD386; DYNJ49888J, Lot Numbers:24AMG698; DYNJ52583G, Lot Numbers:21HBC324; DYNJ52583G, Lot Numbers:21KBM269; DYNJ52583J, Lot Numbers:21LBN305; DYNJ52583L, Lot Numbers:22DBB163; DYNJ52583L, Lot Numbers:22FBF207; DYNJ52583L, Lot Numbers:22HMF439; DYNJ52583L, Lot Numbers:22JMC614; DYNJ52583L, Lot Numbers:23JMF994; DYNJ52583M, Lot Numbers:24CMF962; DYNJ57200A, Lot…
FDA’s list runs to 3,128 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
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 Aug 28, 2024.
- FDA’s Enforcement Report published it on Sep 4, 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 3,128 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
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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.