State

Puerto Rico product recalls

72,940 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.

What the numbers show

Total: 3,090
Critical: 366
Severe: 625
Most recent: 2026-09-02

Of the 3,090 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 625 (20%) are Severe.

Which agencies issued them

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3776–3800 of 76030

HighFDA (Devices)·Z-0992-2026·2025-12-31
Dialysis concentrate 100425 recalled because safety and efficacy cannot be assured
Diasol is recalling 2200 gallons of liquid concentrate for bicarbonate dialysis, product 100425-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2026·2025-12-31
Dialysis concentrate 100125 recalled because safety and efficacy cannot be assured
Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2026·2025-12-31
Dialysis concentrate 100230 recalled because safety and efficacy cannot be assured
Diasol is recalling 4,400 gallons of liquid concentrate for bicarbonate dialysis, product 100230-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2026·2025-12-31
Dialysis concentrate 100225 recalled because safety and efficacy cannot be assured
Diasol is recalling 186,000 containers of liquid concentrate for bicarbonate dialysis, product 100225-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2026·2025-12-31
Femoral nails, 440 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2026·2025-12-31
Femoral nails, 340 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2026·2025-12-31
Infusion drug library software recalled over a failing change review option
ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2026·2025-12-31
Femoral nails, 400 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2026·2025-12-31
Neurostimulator programmer app recalled over a device reset message that persisted
Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0964-2026·2025-12-31
Surgical robot console motors recalled over an error that locks ergonomics
Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors because a connector fault triggers Error 23062 and locks console ergonomics until the motor is replaced.
Product
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2026·2025-12-31
Femoral nails, 320 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609320, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2026·2025-12-31
Dialysis concentrate 100220 recalled because safety and efficacy cannot be assured
Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
Product
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2026·2025-12-31
Digital radiography systems recalled over exceeding the maximum air kerma rate
AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2026·2025-12-31
Infusion software recalled over concentration limits with insufficient decimal precision
ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2026·2025-12-31
Femoral nails, 400 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2026·2025-12-31
Femoral nails, 360 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0984-2026·2025-12-31
Campylobacter control kits recalled because they may fail to recover the organism
Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2026·2025-12-31
Campylobacter LYFO DISK controls recalled over failure to recover the organism
Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0963-2026·2025-12-31
Cranial tracker devices recalled over an error message preventing use
Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0985-2026·2025-12-31
Campylobacter six-pack control kits recalled over failure to recover the organism
Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Product
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25V913000·2025-12-29
Gillig Recalls 2025 Low Floor Buses Due to Loose Axle Fasteners
Gillig is recalling 2025 Low Floor transit buses because improperly tightened rear axle fasteners may cause component damage and increased crash risk.
Product
GILLIG — GILLIG LOW FLOOR
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0913-2026·2025-12-24
Anesthesia systems recalled over potential unexpected shutdown on mains power loss
GE Medical Systems is recalling 1,277 Carestation anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The FDA has classified the action as Class I.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0914-2026·2025-12-24
Carestation 750 anesthesia systems recalled over potential unexpected shutdown
GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestatio
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0915-2026·2025-12-24
Anesthesia power management boards recalled over potential unexpected system shutdown
GE Medical Systems is recalling 203 Carestation anesthesia system Power Management Board field replaceable units over potential unexpected shutdown if AC mains power is lost.
Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2026·2025-12-24
Imaging viewer software recalled over inaccurate length measurement values
DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.
Product
Intelerad InteleShare software, with ProViewer component
Category
Medical Device
Distribution
45 states