FDA Devices Verify with FDA Devices → Moderate Class II Terminated

Product is labeled in part: "MEDLINEExtended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) LengthReorder: ES0016AMContents: 1 EachSINGLE USE ONLYlatexfreeRX OnlySTERILE EOwww.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE*Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2288-2012.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution - including the state of IL..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2288-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: 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.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 7, 2026

Reported: September 5, 2012 Initiated: June 16, 2010 #Z-2288-2012 1440 each units

Unimed Surgical Products, Inc. issued this FDA Devices recall on September 5, 2012. Classified as Moderate severity (Class II). Approximately 1440 each units are affected. The recall was issued because: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Indu…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-2288-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on June 16, 2010. It is classified under Moderate severity (Class II), with a current status of Terminated. Unimed Surgical Products, Inc. is listed as the recalling firm, operating out of Largo, FL. Federal records indicate 1440 each units are affected.

The documented reason for this recall is: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to conce… Distribution data in the federal record shows the product reached: US Nationwide Distribution - including the state of IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

1440 each

Related Recalls

6 from same agency

Product Description

Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.

Reason for Recall

On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

Details

Recalling Firm: Unimed Surgical Products, Inc.
Units Affected: 1440 each
Distribution: US Nationwide Distribution - including the state of IL.
Location: Largo, FL

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-2288-2012
Date reported	September 5, 2012
Date initiated	June 16, 2010
Recalling firm	Unimed Surgical Products, Inc.
Units affected	1440 each
Distribution	US Nationwide Distribution - including the state of IL.

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

Scale of Impact

1440 each units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2288-2012.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution - including the state of IL..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2288-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

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.

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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-07 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).