# FDA recall Z-1072-2023

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

## Product

Sterile Procedural Trays, labeled as the following:  a.	EAR CDS-LF b.	SINUS CDS-1 c.	ZALE FESS CDS d.	ZALE OTOLOGY CDS e.	ZALE HEAD & NECK CDS f.	CUH PARA/THYROIDECTOMY CDS g.	CAM ENDOSCOPIC SINUS/SEPTO CDS h.	HEAD AND NECK CDS i.	HEAD AND NECK CDS-LF j.	NASAL k.	ENT SET UP CDS l.	MINOR ENT SINUS PACK-LF m.	MAJOR EAR PACK-LF n.	THORACOTOMY HARPER PACK-LF o.	FESS NSR PACK-LF p.	ENT BASIC PACK-LF q.	HEAD & NECK-LF r.	ENT PACK-LF s.	SINOSCOPY-LF t.	MAJOR HEAD/NECK PACK-LF u.	NECK PACK v.	HEAD & NECK PACK w.	HEAD & NECK TRAY x.	ENT LAW PACK-LF y.	ENT PACK z.	NECK PACK aa.	NASAL PACK bb.	ENT PACK cc.	FREE FLAP PACK-LF dd.	TYMPANO MASTOID ee.	MINOR HEAD & NECK #40-RF ff.	EAR PACK gg.	E.N.T. TRAY hh.	EAR PACK-LF ii.	BASIC ENT PACK-LF jj.	PLASTIC HEAD & NECK PACK kk.	EAR TRAY #10-RF ll.	HEAD & NECK ENT PACK-RF-LF mm.	ENT PACK nn.	ENT PACK-LF oo.	NASAL/SEPTO PACK pp.	OSC FACE LIFT PK qq.	RRMC NASAL PACK rr.	ENT PACK ss.	HENRYS ENT PACK tt.	ENT uu.	FACE AND NASAL PACK vv.	NASAL PACK ww.	ENT PACK

## 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-1072-2023
- **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-1072-2023

## Citation

> AI Analytics. FDA recall Z-1072-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1072-2023. Source: US FDA. Licensed CC0.

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