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

751–775 of 13414

HighFDA (Devices)·Z-1476-2026·2026-03-11
[pending] cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, m
Pending LLM rewrite. Source: FDA_DEVICE Z-1476-2026.
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-1475-2026·2026-03-11
[pending] GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034
Pending LLM rewrite. Source: FDA_DEVICE Z-1475-2026.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1486-2026·2026-03-11
[pending] CS100 IABP. Software Version CS100 IABP Q.01.
Pending LLM rewrite. Source: FDA_DEVICE Z-1486-2026.
Product
CS100 IABP. Software Version CS100 IABP Q.01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2026·2026-03-11
[pending] Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 S
Pending LLM rewrite. Source: FDA_DEVICE Z-1482-2026.
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
HighFDA (Devices)·Z-1481-2026·2026-03-11
[pending] Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B30
Pending LLM rewrite. Source: FDA_DEVICE Z-1481-2026.
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-1477-2026·2026-03-11
[pending] Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System
Pending LLM rewrite. Source: FDA_DEVICE Z-1477-2026.
Product
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2026·2026-03-11
[pending] Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Numb
Pending LLM rewrite. Source: FDA_DEVICE Z-1491-2026.
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-1492-2026·2026-03-11
[pending] Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6
Pending LLM rewrite. Source: FDA_DEVICE Z-1492-2026.
Product
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1494-2026·2026-03-11
[pending] Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lit
Pending LLM rewrite. Source: FDA_DEVICE Z-1494-2026.
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
HighFDA (Devices)·Z-1493-2026·2026-03-11
[pending] Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-1493-2026.
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
HighFDA (Devices)·Z-1478-2026·2026-03-11
[pending] Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System -
Pending LLM rewrite. Source: FDA_DEVICE Z-1478-2026.
Product
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1452-2026·2026-03-04
[pending] Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Pending LLM rewrite. Source: FDA_DEVICE Z-1452-2026.
Product
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1457-2026·2026-03-04
[pending] Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological ap
Pending LLM rewrite. Source: FDA_DEVICE Z-1457-2026.
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
[pending] Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applica
Pending LLM rewrite. Source: FDA_DEVICE Z-1456-2026.
Product
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2026·2026-03-04
[pending] Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Pending LLM rewrite. Source: FDA_DEVICE Z-1464-2026.
Product
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2026·2026-03-04
[pending] Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Pending LLM rewrite. Source: FDA_DEVICE Z-1468-2026.
Product
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2026·2026-03-04
[pending] Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl
Pending LLM rewrite. Source: FDA_DEVICE Z-1454-2026.
Product
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1458-2026·2026-03-04
[pending] Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, S
Pending LLM rewrite. Source: FDA_DEVICE Z-1458-2026.
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2026·2026-03-04
[pending] Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for
Pending LLM rewrite. Source: FDA_DEVICE Z-1442-2026.
Product
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2026·2026-03-04
[pending] MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used
Pending LLM rewrite. Source: FDA_DEVICE Z-1436-2026.
Product
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2026·2026-03-04
[pending] Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological appli
Pending LLM rewrite. Source: FDA_DEVICE Z-1450-2026.
Product
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2026·2026-03-04
[pending] Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A
Pending LLM rewrite. Source: FDA_DEVICE Z-1465-2026.
Product
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2026·2026-03-04
[pending] Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Pending LLM rewrite. Source: FDA_DEVICE Z-1445-2026.
Product
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2026·2026-03-04
[pending] Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applicat
Pending LLM rewrite. Source: FDA_DEVICE Z-1455-2026.
Product
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2026·2026-03-04
[pending] Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for
Pending LLM rewrite. Source: FDA_DEVICE Z-1446-2026.
Product
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide

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751–775 of 13414