The kit inside the surgical kit was the subject — 11 device records name an included component (Medline)
The U.S. FDA classified 52 units of the Medline Industries surgical convenience kit "HIP CDS-LF" as Class I — its most serious category — because the kit contains an ICU Medical pain management kit (with Bupivacaine Hydrochloride in Dextrose Injection) that had been recalled for quality issues that could result in drug ineffectiveness.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmMedline Industries, LP
- ReasonThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- DistributionUS: Mo, CO, IL
- Recall initiated2026-06-08
Key points
- Recall number Z-2764-2026; FDA Class I, the most serious category; status Ongoing.
- The product is the Medline surgical convenience kit "HIP CDS-LF" (SKU CDS984556N).
- The reason is that an ICU Medical pain management kit inside it (with Bupivacaine Hydrochloride in Dextrose Injection) had been recalled for quality issues that could result in drug ineffectiveness.
- Quantity 52 kits, distributed in Missouri, Colorado, and Illinois.
- Voluntary, firm-initiated. Initiated 2026-06-08; reported 2026-07-29.
- Of the 779 device records this site holds as of 2026-09-01, 11 name a component in the reason.
1What a convenience kit is
Operating rooms and procedure areas widely use convenience kits (procedure kits) that gather the instruments and materials needed for a case into a single pack. They cut preparation work and guarantee that everything required is present. The "HIP CDS-LF" here appears to be a kit for hip procedures, and inside it sat a pain management kit made by a different company as one of its components — a kit within a kit.
2A recall reason that says it may not work
The recorded reason is that the Bupivacaine Hydrochloride in Dextrose Injection inside that ICU Medical pain management kit had been recalled for quality issues that could result in drug ineffectiveness. Bupivacaine is used for local anesthesia. Unlike contamination or a foreign object, the problem here takes the form of the medicine being present but possibly not working.
Pain management failing to perform as expected during a procedure can itself lead to serious consequences, which is why the recall sits in Class I.
352 kits across three states
The quantity is 52 kits, distributed in Missouri, Colorado, and Illinois. A quality issue in one component leads to recalling every kit that contains it — the same cascade seen when a food ingredient recall spreads to downstream products. The difference is that in medical kits each component has a different manufacturer, so the recalling parties differ as well.
4Eleven device records name an included component
Of the 779 device records this site holds as of 2026-09-01, 11 name a component in the reason for recall.
A kit exists to deliver what a procedure needs as one package. When a problem is found in one item inside, the whole kit becomes the unit of recall. Few reasons name the component because, in most cases, only the kit name survives in the record and which item caused it cannot be read.
Why it matters
A convenience kit has as many recall entry points as it has components. Keeping a mapping between kit SKUs and component lots lets a hospital narrow its stock immediately when a component-side recall appears. For the firms that assemble kits, a channel for receiving component makers' recall information and a mechanical way to derive the affected kit SKUs are the central preparations for defining recall scope quickly.
FAQ
What is a convenience kit?
What were the quality issues?
Why is the whole kit recalled?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2764-2026