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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2027%22

Class II recall Z-0082-2027: DRG International, Inc.

Q: How to monitor Class II recall Z-0082-2027: DRG International, Inc. and peer other records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow New Jersey records like this one.

Class II recall Z-0082-2027: DRG International, Inc. (New Jersey): DRG International, Inc. Dated 22 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 17 related NJ FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0082-2027
Recalling firm	DRG International, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Reason	Potential for false negative patient results.
Quantity	211
Distribution	Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
Recall initiated	2026-07-02
Reported	2026-10-14
Firm location	Springfield, NJ, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0082-2027: DRG International, Inc. and 18 New Jersey peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

New Jersey FDAPulse records like this one: 18
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every New Jersey peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 22 days ago.

What is the FDAPulse record for Class II recall Z-0082-2027: DRG International, Inc. in New Jersey?

Class II device recall Z-0082-2027 by DRG International, Inc.: Potential for false negative patient results.

How does Class II recall Z-0082-2027: DRG International, Inc. compare to other New Jersey FDAPulse records?

It is 22 days old, still within a typical 45-day follow-up window.

Class II recall Z-0082-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0082-2027	NJ	2026-10-14
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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