Read the full stored bill text
S4068
SENATE, No. 4068
STATE OF NEW JERSEY
222nd LEGISLATURE
�
INTRODUCED MAY 4, 2026
Sponsored by:
Senator� JOSEPH P. CRYAN
District 20 (Union)
SYNOPSIS
���� Requires manufacturer of recalled medical devices to
provide replacement device or pay for replacement device under certain
circumstances.
CURRENT VERSION OF TEXT
���� As introduced.
��
An Act
concerning medical device manufacturers and
supplementing Title 56 of the Revised Statutes.�
����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:
���� 1.��� a.� As used in this act:
���� "Manufacturer"
means a person engaged in the business of manufacturing or assembling medical
devices.
���� "Medical device" or
"device" means a "device" as defined in subsection (h) of
section 201 of the "Federal Food, Drug and Cosmetic Act," 52 Stat.
1040, (21 U.S.C. s.321).�
���� b.��� If a recall is issued
that requires a consumer to stop using a medical device or to return a medical
device to the manufacturer, the manufacturer shall provide a replacement
medical device to a consumer at no cost, or, if no replacement is available
from the manufacturer, purchase a replacement medical device available from
another manufacturer for the consumer.� A manufacturer shall comply with the
provisions of this subsection as soon as practicable but no later than 30 days
after the recall is issued.�
���� c.���� A violation of
subsection b. of this section shall be an unlawful practice pursuant to
P.L.1960, c.39 (C.56:8-1 et seq.).
���� 2.��� This act shall take
effect immediately.�
STATEMENT
���� This bill requires a
manufacturer of a recalled medical device to provide a replacement device or
pay for a replacement device under certain circumstances.�
���� Under the provisions of this
bill, if a recall is issued that requires a consumer to stop using a medical
device or to return a medical device to the manufacturer, the manufacturer is
to provide a replacement medical device to a consumer at no cost, or, if no
replacement is available from the manufacturer, to purchase a replacement
medical device available from another manufacturer for the consumer.� The bill
provides that a manufacturer is to comply with the provisions of this section
as soon as practicable but no later than 30 days after the recall is issued.�
���� The bill defines
�manufacturer� to mean a person engaged in the business of manufacturing or
assembling medical devices.
���� A violation of the bill�s
provisions is an unlawful practice under the consumer fraud act, P.L.1960, c.39
(C.56:8-1 et seq.).� An unlawful practice is punishable by a monetary penalty
of not more
than $10,000 for a first offense
and not more than $20,000 for any subsequent offense.� In addition, a violation
can result in cease and desist orders issued by the Attorney General, the
assessment of punitive damages, and the awarding of treble damages and costs to
the injured.