# FDA recall Z-1077-2023

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

## Product

Sterile Procedural Trays, labeled as the following:     a.	BREAST AUGMENTATION  b.	BREAST REDUCTION CDS  c.	CUH ABDOMINOPLASTY CDS  d.	ACH PLASTICS BREAST-LF  e.	NE BREAST RECON CDS  f.	PLASTIC SURGERY CDS  g.	MINOR PLASTIC CDS  h.	GROTH BREAST CDS  i.	BREAST ABD  j.	MINOR/U-BAR CDS-LF  k.	PLASTIC BREAST CDS-LF  l.	BREAST-HERNIA-PORT CDS-LF  m.	DAY SURG PLASTIC CDS  n.	PLASTIC SURGERY PACK  o.	PLASTIC PACK-LF  p.	PLASTIC-GENERAL SURGERY PACK  q.	PLASTIC PACK-LF  r.	ABDOMINOPLASTY/BREAST  s.	PLASTIC PACK  t.	BREAST PACK  u.	PLASTIC SURGERY TRAY  v.	BREAST AUGMENTATION PACK  w.	FACE PACK  x.	LIPOSUCTION PACK  y.	UNIVERSAL PLASTIC PACK  z.	PLASTIC PACK  aa.	LIPOSUCTION PACK  bb.	MINOR BREAST PACK  cc.	PLASTICS PACK-LF  dd.	UPPER PLASTIC PACK-LF  ee.	BREAST MAJOR PACK-LF  ff.	CAM PARTIAL MASTECTOMY PACK  gg.	PLASTIC PACK  hh.	BREAST PACK  ii.	BREAST RECONS  COMBO PK XM-LF  jj.	PLASTICS PACK  kk.	BREAST REDUCTION PACK  ll.	BREAST HERNIA PK  mm.	T PLASTY PACK  nn.	ASC PLASTICS PACK  oo.	PLAS

## 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-1077-2023
- **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-1077-2023

## Citation

> AI Analytics. FDA recall Z-1077-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1077-2023. Source: US FDA. Licensed CC0.

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