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

726–750 of 13418

HighFDA (Devices)·Z-1526-2026·2026-03-18
[pending] GEM Premier 5000 PAK; Part No. 00055360010.
Pending LLM rewrite. Source: FDA_DEVICE Z-1526-2026.
Product
GEM Premier 5000 PAK; Part No. 00055360010.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1513-2026·2026-03-18
[pending] Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Pending LLM rewrite. Source: FDA_DEVICE Z-1513-2026.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1532-2026·2026-03-18
[pending] GEM Premier 5000 PAK; Part No. 00055415004.
Pending LLM rewrite. Source: FDA_DEVICE Z-1532-2026.
Product
GEM Premier 5000 PAK; Part No. 00055415004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1543-2026·2026-03-18
[pending] GEM Premier 5000; Part No. 00055445010 & 00055445011.
Pending LLM rewrite. Source: FDA_DEVICE Z-1543-2026.
Product
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2026·2026-03-18
[pending] Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16
Pending LLM rewrite. Source: FDA_DEVICE Z-1550-2026.
Product
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1561-2026·2026-03-18
[pending] Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat
Pending LLM rewrite. Source: FDA_DEVICE Z-1561-2026.
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1518-2026·2026-03-18
[pending] Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Pending LLM rewrite. Source: FDA_DEVICE Z-1518-2026.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1559-2026·2026-03-18
[pending] Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infe
Pending LLM rewrite. Source: FDA_DEVICE Z-1559-2026.
Product
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1551-2026·2026-03-18
[pending] EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP
Pending LLM rewrite. Source: FDA_DEVICE Z-1551-2026.
Product
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2026·2026-03-18
[pending] GEM Premier 5000 PAK; Part No. 00055407504.
Pending LLM rewrite. Source: FDA_DEVICE Z-1528-2026.
Product
GEM Premier 5000 PAK; Part No. 00055407504.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1519-2026·2026-03-18
[pending] Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Pending LLM rewrite. Source: FDA_DEVICE Z-1519-2026.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1522-2026·2026-03-18
[pending] Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Pending LLM rewrite. Source: FDA_DEVICE Z-1522-2026.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2026·2026-03-18
[pending] Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Pending LLM rewrite. Source: FDA_DEVICE Z-1523-2026.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1487-2026·2026-03-11
[pending] CS300 IABP. Software Version CS300 IABP C.01.
Pending LLM rewrite. Source: FDA_DEVICE Z-1487-2026.
Product
CS300 IABP. Software Version CS300 IABP C.01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1484-2026·2026-03-11
[pending] Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Pending LLM rewrite. Source: FDA_DEVICE Z-1484-2026.
Product
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1488-2026·2026-03-11
[pending] Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has
Pending LLM rewrite. Source: FDA_DEVICE Z-1488-2026.
Product
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2026·2026-03-11
[pending] Impella RP Flex with SmartAssist. Product Code: 1000323.
Pending LLM rewrite. Source: FDA_DEVICE Z-1470-2026.
Product
Impella RP Flex with SmartAssist. Product Code: 1000323.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2026·2026-03-11
[pending] Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 h
Pending LLM rewrite. Source: FDA_DEVICE Z-1489-2026.
Product
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2026·2026-03-11
[pending] Impella RP with SmartAssist. Product Code: 0046-0035.
Pending LLM rewrite. Source: FDA_DEVICE Z-1469-2026.
Product
Impella RP with SmartAssist. Product Code: 0046-0035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1479-2026·2026-03-11
[pending] Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Gener
Pending LLM rewrite. Source: FDA_DEVICE Z-1479-2026.
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-1483-2026·2026-03-11
[pending] Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Vers
Pending LLM rewrite. Source: FDA_DEVICE Z-1483-2026.
Product
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 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 percutaneous injection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2026·2026-03-11
[pending] Impella RP. Product Code: 0046-0011.
Pending LLM rewrite. Source: FDA_DEVICE Z-1471-2026.
Product
Impella RP. Product Code: 0046-0011.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1480-2026·2026-03-11
[pending] EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Pending LLM rewrite. Source: FDA_DEVICE Z-1480-2026.
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1485-2026·2026-03-11
[pending] Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: F
Pending LLM rewrite. Source: FDA_DEVICE Z-1485-2026.
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-1490-2026·2026-03-11
[pending] Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Pending LLM rewrite. Source: FDA_DEVICE Z-1490-2026.
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Category
Medical Device
Distribution
Distributed nationwide

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726–750 of 13418