FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Val

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1691-2023.

Q: Where was the recalled product distributed?

Distribution: US Nationwide distribution in the state of VA..

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

Check the product description and recall number (Z-1691-2023) 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 6, 2026

Reported: June 14, 2023 Initiated: April 17, 2023 #Z-1691-2023 1,391 cases (2,972 packs) units

DeRoyal Industries Inc issued this FDA Devices recall on June 14, 2023. Classified as Moderate severity (Class II). Approximately 1,391 cases (2,972 packs) units are affected. The recall was issued because: The custom procedure packs contain light handle covers that have been recalled by another firm.. 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-1691-2023) was formally reported on June 14, 2023, with the manufacturer initiating the action on April 17, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. DeRoyal Industries Inc is listed as the recalling firm, operating out of Powell, TN. Federal records indicate 1,391 cases (2,972 packs) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: The custom procedure packs contain light handle covers that have been recalled by another firm. Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of VA.. 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 3 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

1,391 cases (2,972 packs)

Related Recalls

6 from same agency

Product Description

Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.

Reason for Recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

Details

Recalling Firm: DeRoyal Industries Inc
Units Affected: 1,391 cases (2,972 packs)
Distribution: US Nationwide distribution in the state of VA.
Location: Powell, TN

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	Ongoing
Recall number	Z-1691-2023
Date reported	June 14, 2023
Date initiated	April 17, 2023
Recalling firm	DeRoyal Industries Inc
Units affected	1,391 cases (2,972 packs)
Distribution	US Nationwide distribution in the state of VA.

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

Scale of Impact

1,391 cases (2,972 packs) units affected — million-unit bracket.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) ✓ This recall

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? ▼

The custom procedure packs contain light handle covers that have been recalled by another firm.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1691-2023.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution in the state of VA..

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

Check the product description and recall number (Z-1691-2023) 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.

Recall Guides

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Understanding Recall Severity Classes

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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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PlainMeds →

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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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Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

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 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).