Sterile Procedural Trays, labeled as the following: a
Medical device recall Z-1077-2023. 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
- 6,420 cases (15,009 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. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF
6,420 cases (15,009 units), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. BREAST AUGMENTATION, Item Number: CDS982254L, Case UDI/GTIN: 40195327084791, Unit UDI/GTIN: 10195327084790, Lot Number: 22JBU069,22IBN271; b. BREAST REDUCTION CDS, Item Number: CDS982255I, Case UDI/GTIN: 40195327084807, Unit UDI/GTIN:…
Every code shown here, 1,989 characters
a. BREAST AUGMENTATION, Item Number: CDS982254L, Case UDI/GTIN: 40195327084791, Unit UDI/GTIN: 10195327084790, Lot Number: 22JBU069,22IBN271; b. BREAST REDUCTION CDS, Item Number: CDS982255I, Case UDI/GTIN: 40195327084807, Unit UDI/GTIN: 10195327084806, Lot Number: 22JBB306; c. CUH ABDOMINOPLASTY CDS, Item Number: CDS983176I, Case UDI/GTIN: 40193489767477, Unit UDI/GTIN: 10193489767476, Lot Number: 22JBJ560,22JBD705; d. ACH PLASTICS BREAST-LF, Item Number: CDS983639J, Case UDI/GTIN: 40195327228140, Unit UDI/GTIN: 10195327228149, Lot Number: 22IBF012,22IBF004; e. NE BREAST RECON CDS, Item Number: CDS983660G, Case UDI/GTIN: 40193489952675, Unit UDI/GTIN: 10193489952674, Lot Number: 22IBR079; f. PLASTIC SURGERY CDS, Item Number: CDS983880C, Case UDI/GTIN: 40193489435963, Unit UDI/GTIN: 10193489435962, Lot Number: 22JBT961; g. MINOR PLASTIC CDS, Item Number: CDS984174F, Case UDI/GTIN: 40195327084777, Unit UDI/GTIN: 10195327084776, Lot Number: 22JBM928,22JBM929; h. GROTH BREAST CDS, Item Number: CDS984202U, Case UDI/GTIN: 40195327146307, Unit UDI/GTIN: 10195327146306, Lot Number: 22JBA856,22IBC582,22IBD063; i. BREAST ABD, Item Number: CDS984267J, Case UDI/GTIN: 40193489288873, Unit UDI/GTIN: 10193489288872, Lot Number: 22IBF074; j. MINOR/U-BAR CDS-LF, Item Number: CDS984539J, Case UDI/GTIN: 40193489903189, Unit UDI/GTIN: 10193489903188, Lot Number: 22JDB904; k. PLASTIC BREAST CDS-LF, Item Number: CDS984851K, Case UDI/GTIN: 40195327195398, Unit UDI/GTIN: 10195327195397, Lot Number: 22JDB505; l. BREAST-HERNIA-PORT CDS-LF, Item Number: CDS984853I, Case UDI/GTIN: 40195327071760, Unit UDI/GTIN: 10195327071769, Lot Number: 22JDA801; m. DAY SURG PLASTIC CDS, Item Number: CDS984993O, Case UDI/GTIN: 40195327175765, Unit UDI/GTIN: 10195327175764, Lot Number: 22JBJ441,22JBE422; n. PLASTIC SURGERY PACK, Item Number: DYNJ04750G, Case UDI/GTIN: 40193489511957, Unit UDI/GTIN: 10193489511956, Lot Number: 22JMB163; o. PLASTIC PACK-LF, Item Number: DYNJ0781642R, Case UDI/GTIN:…
FDA’s list runs to 19,508 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 19,508 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.