Recall archive / FDA device enforcement
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS ... — FDA record Z-1093-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
- Reason
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,258 cases (2,154 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1093-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/GTIN: 10888277763524, Lot Number: 22JBO188; m. MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/GTIN: 10195327148195, Lot Number: 22IBA619; n. GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/GTIN: 10889942215928, Lot Number: 22JBM950; o. BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/GTIN: 10888277073265, Lot Number: 22JBN288,22IBD109; p. PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/GTIN: 10193489729993, Lot Number: 22JMD314; q. ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/GTIN: 10193489313765, Lot Number: 22KMA208; r. VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/GTIN: 10193489944228, Lot Number: 22IBJ500; s. GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/GTIN: 10193489996944, Lot Number: 22IDA203; t. VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/GTIN: 10889942444601, Lot Number: 22JDB955; u. TLH PACK, Item Number: DYNJ63145A, Case UDI/GTIN: 40193489979573, Unit UDI/GTIN: 10193489979572, Lot Number: 22JBN742,22IBK842; v. TLH PACK, Item Number: DYNJ80430, Case UDI/GTIN: 40195327038473, Unit UDI/GTIN: 10195327038472, Lot Number: 22HBN532; w. VAG HYST PACK, Item Number: DYNJ82634, Case UDI/GTIN: 40195327199563, Unit UDI/GTIN: 10195327199562, Lot Number: 22JBY522; x. LITHOTOMY-LF, Item Number: DYNJ900721C, Case UDI/GTIN: 40193489951609, Unit UDI/GTIN: 10193489951608, Lot Number: 22KBC673; y. MAJOR LITHOTOMY, Item Number: DYNJ902373I, Case UDI/GTIN: 40195327224760, Unit UDI/GTIN: 10195327224769, Lot Number: 22JBO747; z. LAVH, Item Number: DYNJ903392F, Case UDI/GTIN: 40193489467506, Unit UDI/GTIN: 10193489467505, Lot Number: 22JBR451; aa. LAVH, Item Number: DYNJ904335B, Case UDI/GTIN: 40193489926720, Unit UDI/GTIN: 10193489926729, Lot Number: 22JBU057; bb. D&C / GYN, Item Number: DYNJ906514B, Case UDI/GTIN: 40193489998567, Unit UDI/GTIN: 10193489998566, Lot Number: 22IBP589,22IBD796; cc. LAPAROSCOPIC HYSTERECTOMY, Item Number: DYNJ906844A, Case UDI/GTIN: 40195327025954, Unit UDI/GTIN: 10195327025953, Lot Number: 22JMG630; dd. FS LAP TUBAL LIGATION, Item Number: DYNJ908306, Case UDI/GTIN: 40195327030316, Unit UDI/GTIN: 10195327030315, Lot Number: 22KBE781,22JBO684; ee. LAVH, Item Number: DYNJQ9041Q, Case UDI/GTIN: 40193489850605, Unit UDI/GTIN: 10193489850604, Lot Number: 22JBG106,22IBB420,22IBC141; ff. ABD HYST PACK-LF, Item Number: DYNJT1912G, Case UDI/GTIN: 40888277809056, Unit UDI/GTIN: 10888277809055, Lot Number: 22HBW646; gg. VAG HYST PK-LF, Item Number: DYNJT1913J, Case UDI/GTIN: 40193489976473, Unit UDI/GTIN: 10193489976472, Lot Number: 22IBQ666,22HBU577 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 15, 2023
- Recall initiation date
- Nov 17, 2022
- Center classification date
- Feb 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.