State
73,570 recalls have nationwide distribution and so reach Puerto Rico. 3,094 additional recalls listed Puerto Rico specifically in their distribution scope.
Of the 3,094 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 726 (23%) are Severe.
Which agencies issued them
These figures cover only the 3,094 recalls whose distribution notice names Puerto Rico specifically. The 73,570 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
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.
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.
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.
Mindray DS USA, Inc. is recalling cPM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Mindray DS USA, Inc. is recalling Passport Series Patient Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Mindray DS USA is recalling ePM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Mindray DS USA, Inc. is recalling 133 BeneView T5 and T8 operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.