# FDA recall Z-1091-2023

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

## Product

Sterile Procedural Trays, labeled as the following:      a.	GYN-URO LAPSCP CDS-LF  b.	ROBOTIC CDS  c.	GYN LAPAROSCOPY CDS-LF  d.	GYN LAPAROSCOPY  e.	GYN LAPAROSCOPY CDS  f.	UNIVERSAL ROBOTIC ORLANDO  g.	GYN ROBOTIC CDS  h.	GYN LAPAROSCOPY CDS-1  i.	CUH GYN LAPAROSCOPY CDS  j.	CUH GEN/GYN ROBOTIC CDS  k.	LAVH CDS-LF  l.	GYN LAPAROSCOPY CDS-LF  m.	GYN LAPAROSCOPY CDS UCC-LF  n.	DAY SURG GYN LAP CDS  o.	GYN LAPAROSCOPY CDS  p.	DAVINCI HYSTERECTOMY CDS  q.	GYN LAP/ROBOTIC  r.	DAVINCI PACK-LF  s.	DAVINCI PACK-LF  t.	GYN LAPAROSCOPY PACK-LF  u.	ROBOTIC PACK  v.	GYN LAP - UNIV  w.	BASIC LAVH PACK  x.	GYN/LAPAROSCOPY PACK-LF  y.	LAPAROSCOPIC GYN PACK-LF  z.	DAVINCI PACK-LF  aa.	SCC GYN LAPAROSCOPY PACK  bb.	URO GYN PACK-LF  cc.	GYN LAPAROSCOPY PACK  dd.	TUBAL PACK  ee.	GYN LAP PACK-LF  ff.	LAVH PACK  gg.	GYN LAPAROSCOPY-LF  hh.	LAVH PACK  ii.	PK-GYN-LAPAROSCOPY  jj.	MAJOR LAP PACK 2-LF  kk.	TUBAL PACK  ll.	GYN LAPAROSCOPY PACK-LF  mm.	PK, ROBOTICS-GYN  nn.	SVMMC GEN ROBOTIC PACK  oo.	SVMMC GYN

## 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-1091-2023
- **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-1091-2023

## Citation

> AI Analytics. FDA recall Z-1091-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1091-2023. Source: US FDA. Licensed CC0.

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