Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

901–925 of 13414

HighFDA (Devices)·Z-1341-2026·2026-02-18
Laerdal Compact Suction Unit 4 Recalled for Excessive Electromagnetic Emissions
Laerdal Medical Corporation recalled certain Compact Suction Unit 4 RTCA models because units made during a limited period may emit electromagnetic noise exceeding established RTCA standards.
Product
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2026·2026-02-18
Medline Medical Kits Recalled Due to Potential Open Packaging Seals
Medline Industries is recalling 216 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging that may compromise product sterility.
Product
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2026·2026-02-18
Leksell GammaPlan radiation therapy planning software stereotactic reference error
Leksell GammaPlan software versions 11.3 and 11.4 contain an error in stereotactic reference definition that may cause treatment plans to irradiate incorrect patient locations if the error goes undetected.
Product
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2026·2026-02-18
Medline Catheter Securement Kits Recalled for Potentially Open Applicator Seals
Medline Industries is recalling 1,350 Adult Cath Securement Dressing Kits with potentially open seals on BD ChloraPrep Triple Swabstick applicators. Open packaging may compromise product sterility.
Product
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2026·2026-02-18
Medline Blood Culture Kit Recall Due to Open Applicator Seal
Medline Industries is recalling 4,300 Blood Culture Kits due to open seals on applicator packaging that could compromise sterility and introduce contamination during specimen collection.
Product
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2026·2026-02-18
Medline Circumcision Kit Applicators Recalled for Open Packaging Seals
Medline is recalling specific circumcision kits due to potentially open seals on sterile applicators that could compromise sterility. This affects 168 units distributed nationwide.
Product
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2026·2026-02-18
Philips Spectral CT 7500 fastener torque specification recall
Philips has recalled the Spectral CT 7500 medical imaging device due to fasteners that may not be torqued to specification, potentially allowing rotor parts to become unsecured or displaced. No injuries have been reported.
Product
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2026·2026-02-18
CT Scanner Rotor Fasteners May Become Loose During Operation
Philips Brilliance iCT CT scanners are recalled because fasteners securing the rotor may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or displaced.
Product
Brilliance iCT; Product Code (REF): 728306;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1312-2026·2026-02-18
Medline Suction Catheter Kits Recalled for Wrong Size Catheter
Medline 14 Fr Suction Catheter Kits may contain an 8 Fr catheter instead, potentially causing airway obstruction and respiratory failure. The kits were distributed nationwide and in Canada.
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1317-2026·2026-02-18
Spectral CT scanners may have loose rotor fasteners in gantry
Philips is recalling 283 Spectral CT scanners because fasteners that attach the rotor to the gantry bearing may not be properly torqued, potentially allowing rotor parts to become loose or displaced during operation.
Product
Spectral CT; Product Code (REF): 728333;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2026·2026-02-18
Philips Azurion 3 M15 System Patient Table May Move Unexpectedly
Philips is recalling the Azurion 3 M15 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when locked. This poses a patient safety hazard during interventional procedures.
Product
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1316-2026·2026-02-18
CT Scanner Rotor Fasteners May Not Be Properly Secured in 52 Units
Philips is recalling 52 IQon Spectral CT scanners because fasteners attaching the rotor may not be properly torqued, potentially allowing rotor parts to become displaced or expelled during operation.
Product
IQon Spectral CT; Product Code (REF): 728332;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2026·2026-02-18
da Vinci 5 Surgeon Console Viewer Display Firmware Defect Causes Visualization Loss
A firmware defect in the da Vinci 5 Surgeon Console Viewer Display may cause loss of one or both displays during surgery. When visualization is lost, surgical instruments remain active, risking tissue injury and bleeding.
Product
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1359-2026·2026-02-18
Surepulse VS Cap Large Medical Device Recalled for Incorrect Sizing Guide
Surepulse Medical is recalling the VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to incorrect sizing information in the labeling.
Product
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1357-2026·2026-02-18
Newborn Heart Rate Monitor Cap Has Incorrect Sizing Labeling
Surepulse Medical recalls VS Cap Small components of newborn heart rate monitors due to incorrect sizing guidance in the labeling. The labeling error could affect proper device fit.
Product
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1332-2026·2026-02-18
Medline Suture Removal Trays Recalled Due to Potentially Open Packaging Seals
Medline Industries is recalling 2,448 suture removal kits due to potentially open packaging seals on BD ChloraPrep Triple Swabsticks applicators, which could compromise sterility.
Product
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1360-2026·2026-02-18
Surepulse VS Cap Extra Large Recalled for Incorrect Sizing Guide
The Surepulse VS Cap Extra Large component of newborn heart rate monitors has been recalled because the product labeling contains an incorrect sizing guide.
Product
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1329-2026·2026-02-18
Medline medical convenience kits recalled for open seals on applicators
Medline Industries is recalling 7,570 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potentially open seals on applicator packaging. The kits are distributed nationwide to hospital and clinical settings.
Product
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1337-2026·2026-02-18
Straumann Impression Post Closed Tray Recalled for Color Mismatch in Packaging
Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.
Product
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1356-2026·2026-02-18
Surepulse Newborn Heart Rate Monitor Cap Recalled for Incorrect Sizing Label
Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.
Product
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1358-2026·2026-02-18
FDA Recalls Surepulse Newborn Heart Rate Monitor Cap for Labeling Error
Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.
Product
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1158-2026·2026-02-11
AXIOS Stent Deployment System Recalled Due to Deployment and Expansion Failures
Boston Scientific is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion failures that may require additional surgical or endoscopic intervention.
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1159-2026·2026-02-11
Boston Scientific AXIOS Stent Deployment and Expansion Failure Recall
Boston Scientific is recalling AXIOS stents due to reported deployment and expansion issues. The devices may fail to expand properly during procedures, potentially requiring additional surgical intervention.
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1163-2026·2026-02-11
Boston Scientific AXIOS Stent Deployment and Expansion Issues Recall
Boston Scientific is recalling 588 units of HOT AXIOS biliary stents worldwide due to reports of deployment and expansion failures that may require additional endoscopic or surgical intervention.
Product
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1160-2026·2026-02-11
AXIOS Stent Deployment and Expansion Failures Require Device Exchange or Removal
FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Category
Medical Device
Distribution
Distributed nationwide

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901–925 of 13414