Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, 40” Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, 40” Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, 40” Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, 40” Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall AirLife Adult Manual Resuscitator, 40” Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 6, 2024ClassClass IStatusOngoingWhereCalifornia, Colorado, Florida, Hawaii, Indiana, Missouri, North Carolina and Washington
- Medical device recall MEDLINE TRAY TRACH BASIC SOLUTION Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH… Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE BRONCHOSCOPY TRAY Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE ARTERIAL BUNDLE NO CATHETER Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) Description Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) BREAST PACK Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) C L PREP Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) NUR 105 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: C-SECTION Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) D&C CDS Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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