# FDA recall Z-1093-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-11-17.

## 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 for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

## Key facts

- **Recall number:** Z-1093-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-17
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1093-2023

## Citation

> AI Analytics. FDA recall Z-1093-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1093-2023. Source: US FDA. Licensed CC0.

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