# FDA recall Z-1097-2023

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

## Product

Sterile Procedural Trays, labeled as the following:      a.	KNEE ARTHROSCOPY CDS-LF  b.	ARTHROSCOPY CDS  c.	ARTHROSCOPY LV - EDOC PACK-LF  d.	ARTHROSCOPY PACK-LF  e.	ARTHROSCOPY PACK  f.	ARTHRO PACK-LF  g.	ARTHROSCOPY PACK-LF  h.	ARTHROSCOPY PACK-LF  i.	ARTHROSCOPY KNEE TRAY-LF  j.	ARTHROSCOPY PACK-LF  k.	ARTHROSCOPY BASIN PACK-LF  l.	ARTHROTOMY PACK-LF  m.	ARTHROSCOPY PACK-LF  n.	ARTHROSCOPY PACK  o.	ARTHROSCOPY PACK  p.	ARTHROSCOPY PACK  q.	ARTHROSCOPY PACK - LF  r.	SC ARTHROSCOPY PACK  s.	ARTHROSCOPY PACK-LF  t.	ARTHROSCOPY PACK  u.	ARTHROSCOPY PACK  v.	ARTHROSCOPY PACK  w.	OSC ARTHROSCOPY PK-LF  x.	ARTHROSCOPY PACK  y.	ARTHROSCOPY PACK  z.	ARTHROSCOPY PACK  aa.	ARTHROSCOPY PACK  bb.	ARTHROSCOPY PACK  cc.	KNEE ARTHROSCOPY PACK  dd.	KNEE ARTHROSCOPY PACK  ee.	SHOULDER ARTHROSCOPY PACK  ff.	SHOULDER ARTHROSCOPY  gg.	ARTHROSCOPY PACK  hh.	ARTHROSCOPY PACK  ii.	ARTHROSCOPY PACK  jj.	ARTHROSCOPY PACK  kk.	ARTHROSCOPY PACK  ll.	ARTHROSCOPY PACK-LF  mm.	ARTHROSCOPY KNEE  nn.	ARTHROSCOPY PA

## 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-1097-2023
- **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-1097-2023

## Citation

> AI Analytics. FDA recall Z-1097-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1097-2023. Source: US FDA. Licensed CC0.

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