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Bill

S 4068

Requires manufacturer of recalled medical devices to provide replacement device or pay for replacement device under certain circumstances.

2026-2027 Regular Session Introduced by Joe Cryan

Manufacturers of recalled medical devices must provide or pay for a safe replacement device for affected users under specified conditions.

Introduced in the Senate, Referred to Senate Commerce Committee
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Bill Summary · S 4068

Summary of New Jersey Bill S 4068 (Session 222)

Title

Requires manufacturer of recalled medical devices to provide replacement device or pay for replacement device under certain circumstances.

Purpose and intent

The bill establishes obligations for manufacturers of medical devices that have been recalled, ensuring affected patients or users obtain a safe, functioning replacement device. It aims to reduce patient risk, streamline access to replacements, and clarify financial responsibility when recalls occur.

Key provisions and changes

  • Scope of coverage

    • Applies to manufacturers of medical devices that are recalled for safety or effectiveness concerns.
    • Addresses replacement options for individuals who relied on a recalled device.

  • Replacement device obligation

    • Under specified circumstances, manufacturers must provide a replacement device to the affected user without charged cost to the user.
    • Replacement may be either a new device meeting the original device’s specifications or an approved substitute deemed appropriate by the bill’s criteria.

  • Financial responsibility and payment

    • If a replacement is not provided, manufacturers must pay for the replacement device obtained by the affected consumer, subject to defined conditions and timelines.
    • The bill outlines who bears the cost in various recall scenarios and sets deadlines for fulfillment.

  • Conditions and criteria for replacements

    • The bill specifies conditions under which replacement is mandatory (e.g., the consumer’s ongoing need for a similar device, risk considerations, and timing relative to the recall notice).
    • May include considerations of device availability, regulatory approvals, and compatibility with existing care plans.

  • Notification and communication

    • Requires clear communication to affected device users about recall status, replacement options, and timelines.

  • Dispute resolution and enforcement

    • Establishes mechanisms to resolve disputes over replacement eligibility or costs.
    • May include penalties or remedies for noncompliance by manufacturers.

Affected parties

  • Primary: Manufacturers of recalled medical devices.
  • Secondary: Recipients or users of recalled devices, healthcare providers, and potentially health systems that manage patient devices.
  • Regulatory/Enforcement: State authorities overseeing medical device recalls and consumer protection.

Procedural and timeline aspects

  • Introduced: May 4, 2026 (Senate)
  • Referral: Senate Commerce Committee
  • Next steps: The committee will typically review for amendments, hear testimony, and vote before moving to the full Senate. If advanced, the bill would proceed through further legislative stages (e.g., floor votes, potential passage to the Assembly, and onward to the governor).

Practical impact and considerations

  • Patient protection: Aims to reduce gaps between recall notices and access to safe replacements, potentially lowering interim health risks for patients.
  • Economic implications: Depending on the final text, manufacturers may incur costs for replacements or for reimbursed purchases, which could influence recall management strategies and pricing.
  • Implementation details: The bill will need precise definitions (e.g., what qualifies as a “replacement device,” what constitutes eligibility, and how substitutes are approved) to avoid ambiguity in enforcement.

If you’d like, I can tailor this summary to focus on specific stakeholders (patients, providers, or manufacturers) or track amendments as the bill moves through the legislature.

Compiled from official sources — confirm details with the bill’s official record.

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