Medical DeviceJan 22, 2025
Cardinal Health Presource Kits: 0 ) DESCRIPTION recall — FDA Z-0913-2025
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Monthly breakdown
2025 recalls by month
Select a month to review the recall records reported during that period.
December 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categoriesSeptember 2025285 records · 4 categoriesAugust 2025239 records · 4 categoriesJuly 2025370 records · 4 categoriesJune 2025342 records · 4 categoriesMay 2025258 records · 4 categoriesApril 2025302 records · 4 categoriesMarch 2025259 records · 4 categoriesFebruary 2025260 records · 4 categoriesJanuary 2025354 records · 4 categories
2025 recalls — page 149
Records are ordered by the best available source date.
Medical DeviceJan 22, 2025
ConvaTec Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a recall — FDA Z-0903-2025
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used…
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 recall — FDA Z-0863-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 recall — FDA Z-0869-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number recall — FDA Z-0764-2025
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per…
Class IFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJan 22, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 PRO recall — FDA Z-0893-2025
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
Class IIFDA: OngoingGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 recall — FDA Z-0866-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,COBRA GRASPER,IS4000 REF 471190 recall — FDA Z-0877-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM 630, Model/Catalog recall — FDA Z-0890-2025
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
Class IIFDA: OngoingGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Medical DeviceJan 22, 2025
Boston Scientific ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) recall — FDA Z-0825-2025
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJan 22, 2025
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY recall — FDA Z-0911-2025
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceJan 22, 2025
Abiomed Impella RP with SmartAssist recall — FDA Z-0829-2025
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV)…
Class IFDA: OngoingAbiomed, Inc.
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 recall — FDA Z-0864-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
Sklar Instruments ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI recall — FDA Z-0947-2025
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class IIFDA: OngoingSklar Instruments
Medical DeviceJan 22, 2025
Trokamed GmbH Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic recall — FDA Z-0716-2025
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class IFDA: OngoingTrokamed GmbH
Medical DeviceJan 22, 2025
Sklar Instruments ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS recall — FDA Z-0941-2025
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class IIFDA: OngoingSklar Instruments
Medical DeviceJan 22, 2025
Augustine Surgical Inc recall — FDA Z-0842-2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Class IIFDA: CompletedAugustine Temperature Management, LLC
Medical DeviceJan 22, 2025
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK recall — FDA Z-0912-2025
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceJan 22, 2025
Coloplast Manufacturing US Folysil Silicone Foley Catheters, Device Reference Numbers recall — FDA Z-0844-2025
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Class IIFDA: OngoingColoplast Manufacturing US, LLC
Medical DeviceJan 22, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Infinia II Hawkeye 4 recall — FDA Z-0899-2025
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
Class IIFDA: OngoingGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Medical DeviceJan 22, 2025
Boston Scientific VISIONIST CRT-P, EL recall — FDA Z-0827-2025
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJan 22, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Optima NM/CT 640, Model/Catalog recall — FDA Z-0896-2025
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products…
Class IIFDA: OngoingGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 recall — FDA Z-0855-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceJan 22, 2025
Intuitive Surgical 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 recall — FDA Z-0867-2025
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class IIFDA: OngoingIntuitive Surgical, Inc.
About the 2025 recall archive
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.