FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GR

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1236-2023.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United Arab Emirates..

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

Check the product description and recall number (Z-1236-2023) 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: March 15, 2023 Initiated: January 30, 2023 #Z-1236-2023 5,952 devices units

Carefusion 2200 Inc issued this FDA Devices recall on March 15, 2023. Classified as Moderate severity (Class II). Approximately 5,952 devices units are affected. The recall was issued because: Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container ho…. 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-1236-2023) was formally reported on March 15, 2023, with the manufacturer initiating the action on January 30, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Carefusion 2200 Inc is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records indicate 5,952 devices units are affected.

The documented reason for this recall is: Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, …. 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

5,952 devices

Related Recalls

6 from same agency

Product Description

CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN; 9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE; 10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED; 11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK; 12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE; 13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD; 14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN; 15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE; 16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED; 17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK; 18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE; 19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD; 20. CD5-61B-GREEN, GENESIS LG NARROW 6" PERF BOTTOM GREEN; 21. CD5-61B-PURPLE, GENESIS LG NARROW 6" PERF BOTTOM PURPLE; 22. CD5-61B-RED, GENESIS LG NARROW 6" PERF BOTTOM RED; 23. CD5-61C-BLACK, GENESIS LG NARROW 6" SOLID BOTTOM BLACK 24. CD5-61C-BLUE, GENESIS LG NARROW 6" SOLID BOTTOM BLUE; 25. CD5-61C-GOLD, GENESIS LG NARROW 6" SOLID BOTTOM GOLD; 26. CD5-61C-GREEN, GENESIS LG NARROW 6" SOLID BOTTOM GREEN; 27. CD5-61C-PURPLE, GENESIS LG NARROW 6" SOLID BOTTOM PURPLE; 28. CD5-61C-RED, GENESIS LG NARROW 6" SOLID BOTTOM RED.

Reason for Recall

Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.

Details

Recalling Firm: Carefusion 2200 Inc
Units Affected: 5,952 devices
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United Arab Emirates.
Location: Vernon Hills, IL

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-1236-2023
Date reported	March 15, 2023
Date initiated	January 30, 2023
Recalling firm	Carefusion 2200 Inc
Units affected	5,952 devices
Distribution	Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia…

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

Scale of Impact

5,952 devices 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? ▼

Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1236-2023.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United Arab Emirates..

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

Check the product description and recall number (Z-1236-2023) 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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How the US Recall System Works

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Understanding Recall Severity Classes

What Class I, II, and III mean and which recalls demand immediate action.

What to Do When a Product Is Recalled

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How to Check If Your Products Are Recalled

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Recalled Products in Your Home

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Most Recalled Product Categories

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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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PlainFoodSafe →

Ingredient Safety Data

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PlainIngredients →

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GetFoodFacts →

Drug Safety Information

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PlainMeds →

Product Injury Data

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PlainSafety →

Recall Checker

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Nearby Recalls in This Category

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

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Penner Pacific Bathing Spa, Model Numbers 360020-1P

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FDA Devices Moderate

GEM Premier 5000 PAK, Part No. 00055360004.

Instrumentation Laboratory · 2026-03-18

FDA Devices Moderate

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K. · 2026-03-18

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Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…

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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).