State

Puerto Rico product recalls

72,820 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 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

326–350 of 75910

HighFDA (Devices)·Z-2907-2026·2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2906-2026·2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2026·2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E054000·2026-08-12
Volvo Trucks Recalls Grote Replacement Marker Lights for Visibility Issues
Volvo Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·26E056000·2026-08-12
Odyne Recalls Hybrid Systems Due to Traction Battery Fire Risk
Odyne Systems is recalling certain hybrid systems with specific part numbers because the high-voltage batteries may fail, increasing the risk of a fire.
Product
ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2853-2026·2026-08-12
Quantum Rival Powered Wheelchair Controller Recall for Brake Stop Hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum Rival powered wheelchair controllers due to a software issue that can cause unexpected brake stops while driving, potentially resulting in falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2892-2026·2026-08-12
Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures
Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.
Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 7222
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2877-2026·2026-08-12
FilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2841-2026·2026-08-12
Powered wheelchair controller recalled for unexpected braking hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum 4Front 2 wheelchair controllers because reminder pop-ups can trigger unexpected park brake stops while driving, causing falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2837-2026·2026-08-12
Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips
Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.
Product
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2886-2026·2026-08-12
United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product De
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2851-2026·2026-08-12
Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues
A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2026·2026-08-12
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.
Product
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E055000·2026-08-12
Mack Recalls Grote Replacement Marker Lights for Visibility Failure
Mack Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2894-2026·2026-08-12
5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2883-2026·2026-08-12
Knee Prosthesis Trial Recall for Manufacturing Defect
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
Product
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2860-2026·2026-08-12
Flow Anesthesia Machines Recalled for Failure to Deliver Anesthetic Agent
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
Product
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2849-2026·2026-08-12
Quantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
Pride Mobility Products Corp. is recalling the Quantum Rehab Q6 Edge 3 powered wheelchair controller due to a software issue that can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2890-2026·2026-08-12
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2845-2026·2026-08-12
Powered Wheelchair Controller Software May Cause Unexpected Brake Stop
Pride Mobility is recalling 1,102 Q6 Edge HD powered wheelchairs due to a software issue in the controller that may cause unexpected park brake stops or system crashes when reminder pop-ups appear during use.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2848-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks
The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2865-2026·2026-08-12
Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2893-2026·2026-08-12
Philips Fluoroscopy System Recall Over Hard Disk Drive Issue
Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2901-2026·2026-08-12
COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
Product
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Category
Medical Device
Distribution
Distributed nationwide