Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Onkos Surgical is recalling My3D Personalized Pelvic Implants that were inadvertently mixed up and distributed to incorrect customers.
Cipla USA, Inc. is recalling specific lots of Fosfomycin Tromethamine granules because they failed impurity and degradation specifications.
GRI Medical is recalling Halyard Laparoscopy Comprehensive Pack II kits because they contain a latex urethral catheter despite being labeled as latex-free.
AVID Medical, Inc. is recalling 28 units of EURO053 plastic trays potentially contaminated with manufacturing lubricant. The units were distributed in AZ, CA, FL, MD, NE, and TX.
J&J Innovative Medicine is recalling 49 vials of IMAAVY (nipocalimab-aahu) injection due to the presence of particulate matter. The affected lot was distributed in Ohio.
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules because a software issue can cause test units to revert to defaults without warning, potentially resulting in falsely elevated reported results.
Avid Medical is recalling 124 Open Heart CFH kits because they may be contaminated with a lubricant used during manufacturing.
Avid Medical, Inc. is recalling 144 Davinci Trucustom Bundles because they may be contaminated with a lubricant used during manufacturing.
Limitless Cryo Spa LLC is recalling 219 Glypto Devices and Cryo Machines because they lack FDA 510(k) clearance. The recall covers units distributed nationwide.
AVID Medical, Inc. is recalling 10 Craniotomy Packs (Model WRNM035-20) because they may be contaminated with a lubricant used during manufacturing.
AVID Medical, Inc. is recalling 134 GYN Laparoscopy/Laparotomy kits due to potential contamination with a manufacturing lubricant.
AVID Medical, Inc. is recalling 15 laparoscopic prostatectomy kits because they may be contaminated with a lubricant used during manufacturing.
Quantum Ops Inc is recalling 266 ADAPTABLE Beach Chair surgical patient positioners due to a manufacturing issue involving inadequate welds in the patient head positioning system.
Avid Medical, Inc. is recalling 59 units of Adult Heart Tray Shands Jacks (Model SHND419-08) because they may be contaminated with a lubricant used during manufacturing.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers due to a software issue that may cause test units to revert to defaults without warning, potentially resulting in falsely elevated reported results.
Avid Medical, Inc. is recalling six Robotic Prostatectomy Packs (NAMC423-11) because they may be contaminated with a manufacturing lubricant.
LeMaitre Vascular, Inc. is recalling 54 TufTex Over-the-Wire Embolectomy Catheters because the balloon components may fail under pull force.
WinCo Foods is recalling Salsa Bean Dip Express and 16-inch Catering Trays because they contain recalled peperoncini affected by a pest issue.
PepsiCo is recalling 28 oz. Gatorade beverages in multiple flavors due to undeclared Yellow No. 6 and/or Yellow No. 5.
AVID Medical, Inc. is recalling 40 Major Packs (Model NIHB0018-11) because they may be contaminated with a lubricant used during manufacturing.
AVID Medical, Inc. is recalling 28 GYN Laparoscopy Packs (Model NAMC436-12) because they may be contaminated with a lubricant used during manufacturing.
AVID Medical, Inc. is recalling 23 ABD Hysterectomy kits (Model NAMC438-07) because they may be contaminated with a lubricant used during manufacturing.
Steris is recalling 58 HexaVue Focus Integration Systems because a software issue may cause incorrect patient information to appear on printed images.
Nihon Kohden America LLC is recalling 808 CNS-6200 Series Central Nurse Stations due to a cybersecurity vulnerability that could disrupt patient monitoring.
Shanghai United Imaging Healthcare is recalling 11 uCT ATLAS CT systems due to a software issue that may hide patient images, potentially requiring rescans.