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Recalls & Safety AlertsVersion 6

FDA Classifies Recall of 318 Medline Surgical Kits as Class I

Enforcement report Z-2765-2026 says the knee and hip procedure kits contain recalled ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP.

By AI ReporterUpdated Aug 7, 2026, 9:16 a.m. ET
The U.S. Food and Drug Administration has classified a recall of surgical convenience kits as , the agency's most serious recall category, according to FDA enforcement report . The record gives a recall initiation date of 8 June 2026 and a report and classification date of 29 July 2026. The status is listed as ; this account reflects the record as it currently stands, and the matter remains open and may change. The action covers distributed in Missouri, Colorado and Illinois, the enforcement report states. Six kit configurations are named: TOTAL KNEE-LF (SKUs CDSOPT590T and CDSOPT590U), TOTAL KNEE CDS (CDS983930J), HIP CDS-LF (CDS984556L and CDS984556M) and TOTAL KNEE PACK (DYNJ905162Q). The listed lots are CDSOPT590T lot 24GDA740 (UDI/DI 10195327555009 each, 40195327555000 case); CDSOPT590U lots 26EDA279, 26BDB734, 26ADA474, 25LDA001, 25KDB325, 25GDB517, 25FDB017, 25DDA155 and 24LDA248 (UDI/DI 10198459180255 each, 40198459180256 case); CDS983930J lot 25KBL209 (UDI/DI 10193489512298 each, 40193489512299 case); CDS984556L lots 24JDC180 and 24HDA321 (UDI/DI 10195327554996 each, 40195327554997 case); CDS984556M lot 25ADB327 (UDI/DI 10198459180248 each, 40198459180249 case); and DYNJ905162Q lots 26CBD346 and 25KBU219 (UDI/DI 10198459235900 each, 40198459235901 case). The stated reason is that The FDA defines a recall as one where there is a reasonable probability that use of the product will cause serious harm or death. The agency's enforcement database records no other enforcement action by this firm — a point of context that says nothing about fault in this action. Background on the product category, not on this recall: FDA guidance and regulation define a convenience kit as two or more different medical devices packaged together for the convenience of the user (21 CFR 801.3), intended to stay packaged together and not be substituted, repackaged, re-sterilized or otherwise modified before an end user opens it. Regulators describe such kits as devices packaged together to facilitate a single surgical or medical procedure — here, total knee and hip joint replacement operations. They are not retail products: they are assembled by a kit packager and sold to hospitals and surgical facilities, where a clinician opens the sealed package during a procedure, so anyone affected would be reached through the facility that stocks them.

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Revision history

  1. Version 67 Aug 2026, 13:16current

    No new facts in the record; headline and dek added, wording of the ongoing-status caveat and product background retained unchanged.

  2. Version 57 Aug 2026, 09:50

    Added the remaining listed lot numbers and UDIs for SKUs CDS983930J, CDS984556L, CDS984556M and DYNJ905162Q, and tightened the product-category background with its cited regulatory sources.

  3. Version 47 Aug 2026, 05:13

    Listed the full set of CDSOPT590U lot numbers and tightened the convenience-kit background to match FDA's own wording, removing unsourced descriptions of kit contents.

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