State

Florida product recalls

72,971 recalls have nationwide distribution and so reach Florida. 12,821 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total: 12,821
Critical: 1,765
Severe: 2,975
Most recent: 2026-09-16

Of the 12,821 recalls naming Florida we have scored against our rubric, 1,765 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,975 (23%) are Severe.

Which agencies issued them

These figures cover only the 12,821 recalls whose distribution notice names Florida specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5451–5475 of 85792

HighFDA (Devices)·Z-0023-2026·2025-10-08
Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2026·2025-10-08
Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2026·2025-10-08
Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2026·2025-10-08
Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0677-2025·2025-10-08
Ketorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
Apotex is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution 0.5% because atypical weight loss from improper bottle sealing raises sterility concerns.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0024-2026·2025-10-08
Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches
Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0676-2025·2025-10-08
Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns
Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.
Product
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0004-2026·2025-10-08
Allura Xper FD10 OR Table systems recalled over BIOS battery depletion
Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Product
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2026·2025-10-08
Allura Xper FD10C X-ray systems recalled over premature BIOS battery depletion
Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Product
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2026·2025-10-08
Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Product
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0006-2026·2025-10-08
Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion
Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0013-2026·2025-10-08
Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion
Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0015-2026·2025-10-08
Allura Centron cardiovascular X-ray systems recalled over BIOS battery depletion
Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.
Product
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0675-2025·2025-10-08
Carbamazepine extended release tablets recalled after failing dissolution specifications
American Health Packaging is recalling 360 cartons of Carbamazepine Extended-Release Tablets USP 400 mg from one lot after the product failed dissolution specifications.
Product
CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0008-2026·2025-10-08
Allura Xper FD20 OR Table systems recalled over BIOS battery depletion
Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0014-2026·2025-10-08
Allura Xper CV20 X-ray systems recalled after BIOS battery halts startup
Philips is recalling 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.
Product
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0011-2026·2025-10-08
Allura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.
Product
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2026·2025-10-08
Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion
Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Product
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2026·2025-10-08
Allura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Product
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2026·2025-10-08
Allura Xper FD20 Biplane OR Table systems recalled for BIOS battery failure
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0002-2026·2025-10-08
Entecavir 1 mg tablets recalled for out of specification organic impurity
Zydus is recalling 600 bottles of Entecavir Tablets USP 1 mg from one lot after an individual organic impurity returned an out-of-specification result.
Product
ENTECAVIR — ENTECAVIR (ENTECAVIR)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2025·2025-10-08
Vein ablation generators recalled over software falsely flagging working catheters
BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.
Product
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2026·2025-10-08
Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Product
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0034-2026·2025-10-08
Collagen vascular grafts recalled over unapproved bovine raw material supplier
LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.
Product
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0001-2026·2025-10-08
Entecavir 0.5 mg tablets recalled for out of specification organic impurity
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.
Product
ENTECAVIR — ENTECAVIR (ENTECAVIR)
Category
Drug
Distribution
Distributed nationwide