Medical DeviceDec 31, 2025
Draeger Vapor 3000 recall — FDA Z-0934-2026
A certain component of affected devices was not delivered within specification and contained impurities.
Class IFDA: OngoingDraeger, Inc.
Latest records
Latest recalls — page 99
The newest recall records with useful source details are listed here.
Medical DeviceDec 31, 2025
Alcon Laboratories, Inc. Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03 recall — FDA Z-0939-2026
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Class IFDA: OngoingAlcon Research LLC
Medical DeviceDec 31, 2025
Cook Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100 recall — FDA Z-0994-2026
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not…
Class IIFDA: OngoingCook Inc.
Medical DeviceDec 31, 2025
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system recall — FDA Z-0997-2026
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Class IIFDA: OngoingBeckman Coulter Ireland, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0977-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0967-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0978-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0983-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0976-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Cook R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100 recall — FDA Z-0995-2026
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not…
Class IIFDA: OngoingCook Inc.
Medical DeviceDec 31, 2025
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 recall — FDA Z-0923-2026
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is…
Class IIFDA: OngoingAGFA Healthcare Corp.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0980-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
ICU Medical LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software recall — FDA Z-0966-2026
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use…
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0969-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0971-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0974-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0982-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0968-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Intuitive Surgical da Vinci 5, Surgeon Console Column Motor Connector recall — FDA Z-0964-2026
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceDec 31, 2025
Cook Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) recall — FDA Z-0993-2026
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not…
Class IIFDA: OngoingCook Inc.
Medical DeviceDec 31, 2025
Draeger Vapor 2000 recall — FDA Z-0933-2026
A certain component of affected devices was not delivered within specification and contained impurities.
Class IFDA: OngoingDraeger, Inc.
Medical DeviceDec 31, 2025
Affixus Antegrade Femoral Nails recall — FDA Z-0975-2026
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceDec 31, 2025
Howmedica Osteonics The Stryker CranialMask Tracker is a single-use device consisting of a recall — FDA Z-0963-2026
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability…
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceDec 31, 2025
ICU Medical LifeShield Drug Library Management (DLM) recall — FDA Z-0965-2026
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to…
Class IIFDA: OngoingICU Medical, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
August 2026146 records · 4 categoriesJuly 2026369 records · 4 categoriesJune 2026373 records · 4 categoriesMay 2026334 records · 4 categoriesApril 2026407 records · 4 categoriesMarch 2026180 records · 4 categoriesFebruary 2026329 records · 4 categoriesJanuary 2026211 records · 4 categoriesDecember 2025188 records · 4 categoriesNovember 202597 records · 3 categoriesOctober 2025141 records · 3 categoriesSeptember 2025116 records · 3 categories