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Isolyser/SMS

WCM WASTE & COMPLIANCE MANAGEMENT INC · Model SMS10000 · UDI-DI 00858629005032

FMI

510(k) clearances

39,876

Adverse events (68 deaths)

311

Recalls

452

Facilities

Description

10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.

Recalls

Date	Firm	Reason
2026-07-30	Bard Access Systems, Inc.	After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may exp
2025-06-05	Waismed Ltd.	Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
2025-06-05	Waismed Ltd.	Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
2024-11-19	Greiner Bio-One GmbH	The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
2024-06-18	Embecta Corp.	BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cann
2024-02-05	Retractable Technologies, Inc.	The needle cannula of a retractable needle may detach from the needle holder in the patient.
2023-08-22	Apellis Pharmaceuticals, Inc.	19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural var
2023-07-26	embecta Medical II LLC	Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
2023-07-26	embecta Medical II LLC	Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
2022-06-20	Bard Access Systems, Inc.	BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.