FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Advantice Health — Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY cani…Class III · 2019-04-25
Advantice Health, Llc — Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% …Class III · 2023-02-02
AdvoCare International, LP — SleepWorks Liquid Vitamin & Mineral Herbal Supplement 12 single servi…Class II · 2018-11-12
AdvoCare International, LP — AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement …Class II · 2018-03-30
AdvoCare International, LP — AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product…Class II · 2018-03-30
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject …Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 m…Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 m…Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 …Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 …Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.…Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 …Class II · 2025-07-18
AEQUITA PHARMACY — Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5…Class II · 2025-07-18
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject…Class II · 2025-07-18
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject …Class II · 2025-07-18
AEQUITA PHARMACY — Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.…Class II · 2025-07-18
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5…Class II · 2025-07-18
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject …Class II · 2025-07-18
Aerin Medical, Inc. — Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF…Class II · 2024-11-12
Aero Healthcare — Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per …Class II · 2025-10-17
Aerogen Ltd. — The Aeroneb Professional Nebulizer System is a portable medical devic…Class II · 2014-09-02
Aerogen Ltd. — The Aeroneb Professional Nebulizer System is a portable medical devic…Class II · 2014-09-02
Aerogen Ltd. — The Aeroneb Professional Nebulizer System is a portable medical devic…Class II · 2014-09-02
Aerogen Ltd. — The Aeroneb Professional Nebulizer System is a portable medical devic…Class II · 2014-09-02
Aerolase Corporation — LightPod ERA lasersClass II · 2019-08-01
Aerolase Corporation — LightPod Neo LasersClass II · 2019-08-01
Aesculap AG — AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Class II · 2025-08-18
Aesculap AG — AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Class II · 2025-08-18
Aesculap Implant Systems — Columbus Tibia Plateau (component of the Columbus REVISION Knee Syste…Class II · 2012-02-21
Aesculap Implant Systems LLC — Safil QUI + UNDY 5/0 (1) 45CM DSMP13 SutureClass II · 2016-08-01
Aesculap Implant Systems LLC — NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of …Class II · 2017-08-10
Aesculap Implant Systems LLC — ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR…Class II · 2017-09-05
Aesculap Implant Systems LLC — ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRI…Class II · 2017-09-05
Aesculap Implant Systems LLC — ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTT…Class II · 2017-09-05
Aesculap Implant Systems LLC — The ELAN 4 Air System is intended for high speed cutting, sawing and …Class II · 2017-09-01
Aesculap Implant Systems LLC — JS Series SterilContainer S2 SystemClass II · 2017-09-08
Aesculap Implant Systems LLC — proSA Tool Set used to adjust and verify the proSA Adjustable Shunt S…Class II · 2017-09-21
Aesculap Implant Systems LLC — Gomco Circumcision Clamps with separate O-Ring Component: The device …Class II · 2016-10-28
Aesculap Implant Systems LLC — GN200 Caiman HF generators, electrosurgical, cutting & coagulation & …Class II · 2017-01-09
Aesculap Implant Systems LLC — DS Titanium Ligation Clip, used in laparoscopic surgeryClass II · 2018-01-22
Aesculap Implant Systems LLC — DS Titanium Ligation Clip Appliers, used in laparoscopic surgeryClass II · 2018-01-22
Aesculap Implant Systems LLC — Doyen-Collin Mouth Gag 120MM/ General InstrumentsClass III · 2018-02-16
Aesculap Implant Systems LLC — Strauss Penis Clamp 130MM/General InstrumentsClass III · 2018-02-16
Aesculap Implant Systems LLC — AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R.…Class II · 2019-09-25
Aesculap Implant Systems LLC — ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used wit…Class II · 2019-11-12
Aesculap Implant Systems LLC — RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.Class II · 2021-06-30
Aesculap Implant Systems LLC — LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.Class II · 2021-06-30
Aesculap Implant Systems LLC — Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digit…Class II · 2021-02-19
Aesculap Implant Systems LLC — MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR …Class II · 2021-10-25
Aesculap Implant Systems LLC — ENNOVATE MIS REMOVALKEY SHORT, product code SZ380RClass II · 2020-07-13
Aesculap Implant Systems LLC — ENNOVATE MIS REMOVALKEY SHORT, product code SZ380RClass II · 2020-11-18
Aesculap Implant Systems LLC — Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Ca…Class II · 2023-02-23
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED…Class II · 2020-09-08
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED…Class II · 2020-09-08
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXE…Class II · 2020-09-08
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR V…Class II · 2020-09-08
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR V…Class II · 2020-09-08
Aesculap Implant Systems LLC — AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR V…Class II · 2020-09-08
Aesculap Implant Systems LLC — Aesculap Sterile disposable fleece drape, Product code: GA414, indivi…Class II · 2019-10-01
Aesculap Implant Systems LLC — Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant compo…Class II · 2020-01-21
Aesculap Implant Systems LLC — COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various …Class II · 2020-01-21
Aesculap Implant Systems LLC — COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various …Class II · 2020-01-21
Aesculap Implant Systems LLC — AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various…Class II · 2020-01-21
Aesculap Implant Systems LLC — PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 3…Class II · 2020-04-01
Aesculap Implant Systems LLC — COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, variou…Class II · 2020-01-21
Aesculap Implant Systems LLC — PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., …Class II · 2020-04-01
Aesculap Implant Systems LLC — Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlie…Class II · 2022-07-14
Aesculap Implant Systems LLC — Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting an…Class II · 2023-03-21
Aesculap Implant Systems LLC — Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal mono…Class II · 2022-07-15
Aesculap Implant Systems LLC — AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usag…Class II · 2017-03-07
Aesculap Implant Systems LLC — S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C …Class II · 2012-03-07
Aesculap Implant Systems LLC — GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-R…Class II · 2017-03-28
Aesculap Implant Systems LLC — GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-R…Class II · 2017-03-28
Aesculap Implant Systems LLC — GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE X…Class II · 2017-03-28
Aesculap Implant Systems LLC — Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 …Class II · 2012-07-12
Aesculap Implant Systems LLC — Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,4…Class II · 2023-05-18
Aesculap Implant Systems LLC — Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, S…Class II · 2012-07-25
Aesculap Implant Systems LLC — CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage:…Class II · 2019-08-07
Aesculap Implant Systems LLC — CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: …Class II · 2019-08-07
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System knee implant devices as follows: Catalog/Product…Class II · 2021-03-19
Aesculap Implant Systems LLC — Univation X System Tray Sysem knee implant devices as follows: Tray…Class II · 2021-03-19
Aesculap Implant Systems LLC — For intraventricular indications mainly used for operations within th…Class II · 2023-07-20
Aesculap Implant Systems LLC — PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUClass II · 2021-04-16
Aesculap Implant Systems LLC — PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13Class II · 2021-04-16
Aesculap Inc — Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.…Class II · 2025-09-24
Aesculap Inc — Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS …Class II · 2025-09-24
Aesculap Inc — Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS …Class II · 2025-09-24
Aesculap Inc — Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM…Class II · 2025-09-24
Aesculap Inc — MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", …Class II · 2023-12-29
Aesculap Inc — MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm…Class II · 2023-12-29
Aesculap Inc — DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use i…Class II · 2024-01-09
Aesculap Inc — DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparos…Class II · 2024-01-09
Aesculap Inc — DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in…Class II · 2024-01-09
Aesculap Inc — DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in…Class II · 2024-01-09