Recalls published in December 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in December 2025, newest first.
-
Class II · 10 months ago
GE Healthcare GmbH GE HealthCare ViewPoint 6 recall: GE HealthCare has become aware that the Patient History tab in ViewPoint 6
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete…
-
Class II · 10 months ago
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during…
-
Class II · 10 months ago
AVID Medical, Inc. Halyard, Midtown General Arteriogram recall: Potential for incomplete seal on header bag
Potential for incomplete seal on header bag.
-
Class II · 10 months ago
Abbott Laboratories Alinity ci-series System Control Module , REF: 03R70-01, 03R70-20 recall: Abbott Laboratories is recalling their Alinity ci-series System Control
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the…
-
Class II · 10 months ago
Myofunctional Research Company USA Myosa for Kids KS1 REF MyOsaks1_Sb/Sp/Mb/Mp/Lb/Lc recall: Due to firm mistakenly distributing product within the U.S. without FDA
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
-
Class II · 10 months ago
Path Madsen Accuscreen Teoae/Dpoae/ABR Probe recall: Following a component change in the DPOAE probe (speaker replacement)
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with…
-
Class II · 10 months ago
Mindray North America Hardware configuration of the BeneVision Central Monitoring recall: When the Worstation of the BeneVision DMS has a specific hardware
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen…
-
Class II · 10 months ago
Zimmer Air Dermatome, Model/ recall: The devices may have a misaligned thickness control bar
The devices may have a misaligned thickness control bar.
-
Class III · 10 months ago
Instrumentation Laboratory HemosIL SynthAFax. Partial Thromboplastin Time Tests recall: Recalled lots were manufactured with double the amount of preservative
Recalled lots were manufactured with double the amount of preservative concentration.
-
Class II · 10 months ago
Smith & Nephew, Inc. Biosure HA Screw, 6MM x 20 MM. Threaded metallic bone fixation recall: Removal of affected lot of screws due to labeling error
Removal of affected lot of screws due to labeling error.
-
Class II · 10 months ago
Cepheid Brand Name: Xpert¿ BCR-ABL Ultra Model/ recall: Invitro diagnostic test kits with specimens that have elevated white blood
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. Lidocaine HCI 2% and Epinephrine 1:100,000 recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. Cook-Walte, Carbocaine 3% recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class III · 10 months ago
Somerset Therapeutics LLC Cisatracurium Besylate Injection USP, 10 mg/5 mL* recall: Subpotent product:out of specification assay results observed during long
Subpotent product:out of specification assay results observed during long term stability testing.
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. OraVerse, Injection, 0.4 mg/1.7mL recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. 2% Xylocaine Dental with Epinephrine 1:100,000 recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class III · 10 months ago
Somerset Therapeutics LLC Cisatracurium Besylate Injection USP, 200mg/20mL* recall: Subpotent product:out of specification assay results observed during long
Subpotent product:out of specification assay results observed during long term stability testing.
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. 3% Polocaine Dental recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. darby dental supply, Mepivacaine recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class II · 10 months ago
Preferred Pharmaceuticals, Inc. Ondansetron ODT Tablets, USP 4mg recall: Defective container: Preferred Pharmaceuticals received a letter
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
-
Class II · 10 months ago
Novocol Pharmaceutical of Canada, Inc. Benco dental Graham Chemical CO recall: Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
-
Class III · 10 months ago
Somerset Therapeutics LLC Cisatracurium Besylate Injection USP, 20 mg/10 mL* recall: Subpotent product:out of specification assay results observed during long
Subpotent product:out of specification assay results observed during long term stability testing.
-
Class II · 10 months ago
Sun Pharma /Taro Ciclopirox Shampoo, 1%, 120 mL recall: Failed Impurity/Degradation specifications: OOS results obtained
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
-
Class II · 10 months ago
Golden State Medical Supply Inc. Baclofen Tablets USP, 10 mg, 1000-count bottles recall: Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules