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

1701–1725 of 13384

HighFDA (Devices)·Z-0535-2026·2025-11-26
[pending] Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 3
Pending LLM rewrite. Source: FDA_DEVICE Z-0535-2026.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0487-2026·2025-11-19
[pending] Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir,
Pending LLM rewrite. Source: FDA_DEVICE Z-0487-2026.
Product
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0498-2026·2025-11-19
[pending] Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit
Pending LLM rewrite. Source: FDA_DEVICE Z-0498-2026.
Product
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2026·2025-11-19
[pending] Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-0452-2026.
Product
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse tra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2026·2025-11-19
[pending] Radiography 7300 C; Model Number: 712037;
Pending LLM rewrite. Source: FDA_DEVICE Z-0466-2026.
Product
Radiography 7300 C; Model Number: 712037;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2026·2025-11-19
[pending] Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitativ
Pending LLM rewrite. Source: FDA_DEVICE Z-0501-2026.
Product
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0455-2026·2025-11-19
[pending] B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6
Pending LLM rewrite. Source: FDA_DEVICE Z-0455-2026.
Product
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2026·2025-11-19
[pending] CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batte
Pending LLM rewrite. Source: FDA_DEVICE Z-0454-2026.
Product
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2026·2025-11-19
[pending] Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10
Pending LLM rewrite. Source: FDA_DEVICE Z-0471-2026.
Product
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2026·2025-11-19
[pending] Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA
Pending LLM rewrite. Source: FDA_DEVICE Z-0486-2026.
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2026·2025-11-19
[pending] Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10
Pending LLM rewrite. Source: FDA_DEVICE Z-0469-2026.
Product
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0465-2026·2025-11-19
[pending] DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 71
Pending LLM rewrite. Source: FDA_DEVICE Z-0465-2026.
Product
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0470-2026·2025-11-19
[pending] Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 c
Pending LLM rewrite. Source: FDA_DEVICE Z-0470-2026.
Product
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2026·2025-11-19
[pending] Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT
Pending LLM rewrite. Source: FDA_DEVICE Z-0474-2026.
Product
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2026·2025-11-19
[pending] Precision CRF; Model Number: 706400;
Pending LLM rewrite. Source: FDA_DEVICE Z-0463-2026.
Product
Precision CRF; Model Number: 706400;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0477-2026·2025-11-19
[pending] Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 c
Pending LLM rewrite. Source: FDA_DEVICE Z-0477-2026.
Product
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2026·2025-11-19
[pending] CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FC
Pending LLM rewrite. Source: FDA_DEVICE Z-0434-2026.
Product
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0444-2026·2025-11-19
[pending] Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEM
Pending LLM rewrite. Source: FDA_DEVICE Z-0444-2026.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2026·2025-11-19
[pending] SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold a
Pending LLM rewrite. Source: FDA_DEVICE Z-0481-2026.
Product
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0493-2026·2025-11-19
[pending] Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Pending LLM rewrite. Source: FDA_DEVICE Z-0493-2026.
Product
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2026·2025-11-19
[pending] VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow P
Pending LLM rewrite. Source: FDA_DEVICE Z-0500-2026.
Product
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2026·2025-11-19
[pending] Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Pending LLM rewrite. Source: FDA_DEVICE Z-0458-2026.
Product
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0502-2026·2025-11-19
[pending] Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quali
Pending LLM rewrite. Source: FDA_DEVICE Z-0502-2026.
Product
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and ant
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0459-2026·2025-11-19
[pending] Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Pending LLM rewrite. Source: FDA_DEVICE Z-0459-2026.
Product
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0479-2026·2025-11-19
[pending] BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0479-2026.
Product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Category
Medical Device
Distribution
Distributed nationwide

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1701–1725 of 13384