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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

MEDLINE INDUSTRIES, LP - Northfield: Various Medical Convenience Kits Recalled Due to Defective Surgical Tool

Agency Publication Date: December 5, 2024
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Summary

Medline Industries is recalling approximately 714,741 medical convenience kits used in various surgical procedures, including cardiovascular, neurological, and maternity care. These pre-packaged kits contain specific lots of the SafeAir Smoke Evacuation Pencil that were previously recalled by the original manufacturer, Stryker, because of potential defects. Consumers and healthcare providers should identify any kits with the affected lot numbers in their inventory and contact the manufacturer for guidance on how to handle or return the impacted units. If you are a patient concerned about a recent surgery, you should contact your healthcare provider for more information.

Risk

The kits contain a defective smoke evacuation component that may fail to properly clear surgical smoke or could fail during use. This poses a risk of procedure delays or potential exposure to surgical smoke during a medical operation.

What You Should Do

  1. Check the labels of your Medline convenience kits for the REF (reference) and Lot numbers provided in the detailed recall list.
  2. Identify high-volume affected kits such as the ABDOMINAL LAPAROSCOPY (REF CDS760057K), C-SECTION OR 30 CDS (REF CDS820075V), and TRACH TOTE (REF DYNJ85691).
  3. Inspect packaging for specific lot numbers, for example, Lot 24ABR853 for Trach Totes or Lot 22EBV549 for Acetabular Packs.
  4. If a kit is found to be part of the recall, stop using it immediately and set it aside to prevent use in a medical procedure.
  5. Contact Medline Industries, LP - Northfield for instructions on returning affected products or obtaining a remedy.
  6. Healthcare facilities should consult their internal supply chain records to identify and quarantine any impacted inventory.
  7. For further questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Healthcare facilities should identify and stop use of affected kits containing the Stryker smoke evacuation pencil.

How to: Contact your healthcare provider or the manufacturer, Medline Industries, LP, for further instructions and potential refund or replacement options.

Affected Products

Product: TRACH TOTE Convenience Kit
Model / REF:
REF DYNJ85691
UDI/DI 10195327534141
Lot Numbers:
24ABR853
Product: TRACHEOSTOMY Convenience Kit
Model / REF:
REF DYNJ902123J
UDI/DI 10195327497453
Lot Numbers:
23JDB498
24DDA877
24CDB678
24BDB737
Product: ACETABULAR PACK-LF Medical Convenience Kit
Model / REF:
REF DYNJ0572894I
UDI/DI 10195327045975
Lot Numbers:
22EBV549
22FBV442
23ABU908
22LBG711
23CBJ089
23BBM090
23GBS959
23JBG841
Product: LOCAL BASIC Medical Convenience Kit
Model / REF:
REF DYNJ34418L
UDI/DI 10193489969276
Lot Numbers:
23CBT026
23ABO601
Product: ANGIO PACK #2 Convenience Kit
Model / REF:
REFDYNJ39185D
UDI/DI 10195327157166
Lot Numbers:
22GBA088
22FBS934
22HBA086
Product: C-SECTION OR 30 CDS Convenience Kit
Model / REF:
REF CDS820075V
UDI/DI 10193489846973
Lot Numbers:
22GBP851
Product: ABDOMINAL LAPAROSCOPY Convenience Kit
Model / REF:
REF CDS760057K
UDI/DI 10195327274368
Lot Numbers:
23ABU244
22LBC409
23GBN928
23CBO552
23EBA183
23JBH987
Product: BASIC NEURO PACK Convenience Kit
Model / REF:
REF CDS780202P
UDI/DI 10195327096458
Lot Numbers:
22IMA512
22IMA513
22FMD852
22GME200
22FMH471
22LMA065
Product: ZALE HEAD & NECK CDS Convenience Kit
Model / REF:
REF CDS983184I
UDI/DI 10195327178352
Lot Numbers:
22LBB795
23FBJ754
23BBH106
23CBT619
23HBY087
23HBP974
23KBI669
23LBD939
23KBM394
Product: GENDER AFFIRMING SURGERY Convenience Kit
Model / REF:
REFDYNJ66252A
UDI/DI 10193489887853
Lot Numbers:
22OBL262

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95621
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized Medical Distributors; Hospitals; Surgical Centers; Clinics
Manufactured In: United States
Units Affected: 27 products (88 units; 182 units; 1271 units; 30092 units; 980 units; 944 units; 24754 units; 167074 units; 70 units; 44 units; 25877 units; 14388 units; 102561 units; 36 units; 486 units; 66 units; 30 units; 12847 units; 1952 units; 336 units; 13057 units; 828 units; 58765 units; 3452 units; 478 units; 1921 units; 252162 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.