MEDLINE INDUSTRIES, LP - Northfield Nonsterile convenience kits: a recall — FDA Z-2229-2024
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Complete FDA and NHTSA recall records dated in 2024, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process…
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical…
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies…
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days…
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not…
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy…
Expired Products distributed to customers
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various…
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards…
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards…
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release…
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.