Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potentia…

Recall #: Z-2976-2018
Affected scope: 3,000 kits
Initiated: April 12, 2017

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Medline Industries, Inc. recalled Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. - a moderate-severity action.

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. was recalled by Medline Industries, Inc. in September 12, 2018. Reason: Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #5265…. Check the official notice for the remedy. Verify recall #Z-2976-2018 with the FDA Devices before acting.

The recall

Medline Industries, Inc. issued this moderate-severity FDA Devices recall-Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #5265….

Moderate
severity level: Class II
classification: September 12, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2976-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

Reason for recall

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2976-2018
Date reported	September 12, 2018
Date initiated	April 12, 2017
Recalling firm	Medline Industries, Inc.
Firm location	Waukegan, IL
Affected scope	3,000 kits
Distribution	CA, NM

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2976-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.. Recalled by Medline Industries, Inc.. Units affected: 3,000 kits.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2976-2018.

Where was the recalled product distributed? ▼

Distribution: CA, NM.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Megestrol Acetate Oral Suspension, USP 40… 2018-09-12 AvKARE Valsartan and Hydrochlorothiazide … 2018-09-12 AvKARE Valsartan and Hydrochlorothiazide … 2018-09-12 AvKARE Valsartan and Hydrochlorothiazide … 2018-09-12

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

AutoDELFIA Neonatal immunoreactive trypsi… 2018-09-12 AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO ma… 2018-09-12 Overhead Counterpoise Systems (OCS), OCS … 2018-09-12 Overhead Counterpoise Systems (OCS) OCS C… 2018-09-12

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported September 12, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026