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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1651–1675 of 13384

HighFDA (Devices)·Z-0538-2026·2025-11-26
[pending] OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-0538-2026.
Product
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0572-2026·2025-11-26
[pending] Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Ne
Pending LLM rewrite. Source: FDA_DEVICE Z-0572-2026.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0524-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPA
Pending LLM rewrite. Source: FDA_DEVICE Z-0524-2026.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog N
Pending LLM rewrite. Source: FDA_DEVICE Z-0561-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2026·2025-11-26
[pending] Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Pending LLM rewrite. Source: FDA_DEVICE Z-0566-2026.
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Ca
Pending LLM rewrite. Source: FDA_DEVICE Z-0552-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH
Pending LLM rewrite. Source: FDA_DEVICE Z-0523-2026.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2026·2025-11-26
[pending] Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test A
Pending LLM rewrite. Source: FDA_DEVICE Z-0569-2026.
Product
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0509-2026·2025-11-26
[pending] MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Pending LLM rewrite. Source: FDA_DEVICE Z-0509-2026.
Product
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-0559-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2026·2025-11-26
[pending] Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 4
Pending LLM rewrite. Source: FDA_DEVICE Z-0571-2026.
Product
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0488-2026·2025-11-26
[pending] TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Pending LLM rewrite. Source: FDA_DEVICE Z-0488-2026.
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0508-2026·2025-11-26
[pending] Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 10
Pending LLM rewrite. Source: FDA_DEVICE Z-0508-2026.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catal
Pending LLM rewrite. Source: FDA_DEVICE Z-0548-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF
Pending LLM rewrite. Source: FDA_DEVICE Z-0526-2026.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2026·2025-11-26
[pending] SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Mode
Pending LLM rewrite. Source: FDA_DEVICE Z-0555-2026.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2026·2025-11-26
[pending] Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Mode
Pending LLM rewrite. Source: FDA_DEVICE Z-0534-2026.
Product
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presen
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0512-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Pending LLM rewrite. Source: FDA_DEVICE Z-0512-2026.
Product
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2026·2025-11-26
[pending] BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Pending LLM rewrite. Source: FDA_DEVICE Z-0504-2026.
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2026·2025-11-26
[pending] SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Pending LLM rewrite. Source: FDA_DEVICE Z-0565-2026.
Product
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0554-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube,
Pending LLM rewrite. Source: FDA_DEVICE Z-0554-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2026·2025-11-26
[pending] Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630
Pending LLM rewrite. Source: FDA_DEVICE Z-0540-2026.
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2026·2025-11-26
[pending] DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytomete
Pending LLM rewrite. Source: FDA_DEVICE Z-0541-2026.
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2026·2025-11-26
[pending] Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, H
Pending LLM rewrite. Source: FDA_DEVICE Z-0507-2026.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0573-2026·2025-11-26
[pending] Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Produ
Pending LLM rewrite. Source: FDA_DEVICE Z-0573-2026.
Product
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER
Category
Medical Device
Distribution
0 states

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1651–1675 of 13384