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

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751–775 of 13398

HighFDA (Devices)·Z-1476-2026·2026-03-11
Medical Diagnostic Analyzer Software Defect Causes Erroneous Lab Results
A software defect in Roche's cobas pro automated diagnostic analyzer allows erroneous calibrations, causing the system to repeat previous results instead of calculating new values, potentially leading to incorrect patient lab results.
Product
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystati
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1481-2026·2026-03-11
B. Braun Winged Infusion Needle Recalled for Dull or Broken Needle Tips
B. Braun is recalling approximately 105,550 BBraun Medical 21G X4.4CM Winged Infusion Needles due to potential for needle tips to be dull, blunt, or prone to breaking.
Product
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percut
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1490-2026·2026-03-11
Esaote Endocavity Ultrasonic Probe Recalled for Potential Liquid Leak
Esaote is recalling Endocavity ultrasonic probes (Model E 3-12) due to a potential weakness that may cause liquid leakage from the cable terminal area. Five units distributed in North Carolina and Texas are affected.
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1480-2026·2026-03-11
Toric Implantable Collamer Lens Recall: Mislabeled Length May Cause Angle Closure
Staar Surgical is recalling 7 EVO+ Visian Toric Collamer Lenses (Model VTICM5) that were labeled as 12.1 mm but are actually 12.6 mm. The oversized lenses may cause excessive vault, leading to angle closure and elevated intraocular pressure requiring lens exchange.
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1485-2026·2026-03-11
Aesculap MINOP Trocar Recalled for Potential Shaft Length Defect
Aesculap Inc. is recalling 126 units of its MINOP TROCAR 150MM surgical instrument (Model FF399R) because the trocar shaft may be longer than specification. The affected units were distributed to healthcare facilities nationwide.
Product
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2026·2026-03-11
Medical Device Recall: Free Protein S Test Kit Results May Be Inaccurate
Diagnostica Stago is recalling STA Liatest Free Protein S diagnostic kits that may produce inaccurate test results, underestimating free protein S levels in patient plasma samples.
Product
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2026·2026-03-11
B. Braun Infusion Needle Recall: Potential Dull or Broken Needle Tip
B. Braun is recalling 21,000 units of its 21GA WINGED INFUSION needle due to the potential for needle tips to be dull, blunt, or break during use. The defect affects subcutaneous implant procedures.
Product
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneou
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1486-2026·2026-03-11
CS100 IABP Medical Device Battery Specifications Documentation Update
Datascope Corp. is updating battery runtime and cycle specifications in the technical documentation for the CS100 IABP cardiac support device distributed worldwide.
Product
CS100 IABP. Software Version CS100 IABP Q.01.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1487-2026·2026-03-11
CS300 IABP battery runtime and cycle specifications require correction
Datascope Corp. is updating battery runtime and cycle specifications in the CS300 IABP Instructions for Use. No illnesses or injuries reported.
Product
CS300 IABP. Software Version CS300 IABP C.01.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1494-2026·2026-03-11
Olympus ShockPulse-SE Lithotripsy System Generator Mis-wired Component Recall
Olympus ShockPulse-SE lithotripsy system generators have a mis-wired component causing electrical noise that violates electromagnetic compatibility standards. This may reduce system reliability and delay kidney stone treatment. 55 units affected in Canada, Germany, Singapore, Australia, and India.
Product
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1493-2026·2026-03-11
Sound Processor Labeling Mismatch on Cochlear Implant Units
Advanced Bionics is recalling 2 units of the Sky CI M90 Sound Processor due to a packaging label that does not match the product inside. Users should verify device specifications before use.
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1479-2026·2026-03-11
Olympus ShockPulse-SE Lithotripsy Generator Recalled for Transducer Recognition Failure
Olympus is recalling the ShockPulse-SE Lithotripsy System generator because damage to the transducer plug or generator receptacle may cause the device to remain in a blinking state and fail to recognize the transducer. The 1,684 affected units were distributed worldwide.
Product
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2026·2026-03-04
Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk
Olympus Corporation of the Americas is recalling the Olympus Resection Sheath (Model A22042T) due to reports that the ceramic tip can break. The defect affects 1,634 units distributed nationwide.
Product
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2026·2026-03-04
Olympus Inner Sheath Urological Endoscope Model A2660T Recall
Olympus is recalling Inner Sheath 21 Fr. endoscopes due to complaints of ceramic tip breakage during use. The broken tip could cause tissue damage in urological procedures.
Product
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1434-2026·2026-03-04
Medline Nail Kit Recalled for Sterile Saline Wound Wash Sterility Failure
Medline has recalled certain Nail Kits because the sterile saline wound wash component may not meet required sterility standards. The affected kits were distributed nationwide and internationally.
Product
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2026·2026-03-04
Olympus Resection Sheath with Ceramic Tip Fracture Risk
Olympus is recalling 1,676 units of the Resection Sheath Model A22042A nationwide due to reports that the ceramic tip can break. The device is used in urologic procedures.
Product
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2026·2026-03-04
Medline Dialysis Dressing Change Kits Recalled for Defective Tego Connectors
Medline Industries is recalling approximately 31,848 dialysis dressing change kits with defective Tego Connectors. Silicone seals may crack or dome, potentially blocking fluid flow, causing therapy delays, or allowing biological contamination.
Product
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2026·2026-03-04
Medical device distributed without FDA 510(k) pre-market clearance
Edermy LLC is recalling PIE PAK medical device models due to lack of FDA 510(k) clearance. Approximately 11,200 units were distributed nationwide without required regulatory approval.
Product
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2026·2026-03-04
Olympus Resection Inner Sheath recalled for ceramic tip fractures
Olympus Corporation of the Americas is recalling the Resection Inner Sheath (Model No. A22040T) used in urologic procedures due to complaints of ceramic tip breaking. Approximately 7,426 units were distributed nationwide.
Product
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2026·2026-03-04
Medline Tego Connector Kits Recalled for Silicone Seal Defects
Medline is recalling 1,212 units of kits containing Tego Connectors due to silicone seal defects that may block fluid flow, cause therapy delays, or allow air and biological contaminants to enter the body. No illnesses have been reported.
Product
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1457-2026·2026-03-04
Olympus Resection Sheath ceramic tip breakage medical device recall
Olympus Corporation is recalling the Olympus Resection Sheath Model A2666T due to complaints of the ceramic tip breaking. The device is used for urological procedures and distributed nationwide.
Product
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2026·2026-03-04
Olympus Inner Sheath Model A2642 Recalled for Breaking Ceramic Tip
Olympus is recalling the Inner Sheath Model A2642 urological endoscope due to complaints that the ceramic tip breaks. The device has been distributed nationwide.
Product
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2026·2026-03-04
Olympus Resection Sheath ceramic tip breaking recalled nationwide
Olympus is recalling 207 units of a resection sheath (Model A22043T) due to complaints that the ceramic tip breaks. The device is used in urologic surgical procedures.
Product
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1473-2026·2026-03-04
Octopus Nuvo Tissue Stabilizer recalled for tubing assembly error
Medtronic is recalling Octopus Nuvo Tissue Stabilizer units due to an assembly error where tubing was incorrectly positioned. The short tube was attached to the bottom instead of the top, contrary to design specifications.
Product
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2026·2026-03-04
Olympus Inner Sheath medical device recalled due to ceramic tip breakage
Olympus Corporation is recalling 1,141 units of the Inner Sheath, Long (Model WA22017T) used in urological and gynecological procedures due to complaints of ceramic tip breakage.
Product
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Category
Medical Device
Distribution
Distributed nationwide

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751–775 of 13398