State

Puerto Rico product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3126–3150 of 76026

CriticalFDA (Devices)·Z-1325-2026·2026-02-18
Reprocessed AcuNav catheters recalled over residual material particles inside
Medline is recalling 511 reprocessed Siemens ACUSON AcuNav diagnostic ultrasound catheters because these lots may contain small particles of residual material.
Product
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2026·2026-02-18
Azurion 7 B12 systems recalled over tables that may move unexpectedly
Philips is recalling 655 units of the Azurion 7 B12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.
Product
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0338-2026·2026-02-18
Oxycodone blister cards recalled over seals that let tablets fall out
Amerisource Health Services is recalling 31,676 packages of Oxycodone Hydrochloride Tablets 5 mg over card seal defects that let tablets fall out of their cavities.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2026·2026-02-18
Azurion 5 M12 systems recalled over tables that may move unexpectedly
Philips is recalling 326 units of the Azurion 5 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.
Product
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2026·2026-02-18
Vascular access kits and trays recalled over open swabstick seals
Medline is recalling 21,854 units of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2026·2026-02-18
Blood culture kits recalled over open swabstick applicator seals
Medline is recalling 4,300 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0322-2026·2026-02-18
Testosterone 87.5mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 62,581 pellets of Testosterone, 87.5 mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2026·2026-02-18
Port and line access kits recalled over open swabstick applicator seals
Medline is recalling 7,570 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2026·2026-02-18
Azurion 7 B20 systems recalled over tables that may move unexpectedly
Philips is recalling 1 of the Azurion 7 B20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.
Product
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0311-2026·2026-02-18
Estradiol 18mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 1,699 pellets of ESTRADIOL, 18 mg sterile pellets over the potential presence of metal particulate matter.
Product
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2026·2026-02-18
Surgeon console displays recalled over firmware that can lose visualization
Intuitive Surgical is recalling 47 da Vinci 5 Surgeon Console Viewer Displays manufactured with outdated firmware, which may cause loss of the 3D surgical field or complete visualization loss.
Product
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0319-2026·2026-02-18
Testosterone 37.5mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 60,868 pellets of Testosterone, 37.5 mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0314-2026·2026-02-18
Estradiol 25mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 2,442 pellets of ESTRADIOL, 25 mg sterile pellets over the potential presence of metal particulate matter.
Product
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0335-2026·2026-02-18
Thiamine injection bags recalled over a lack of assurance of sterility
Fresenius Kabi Compounding is recalling 10,548 bags of thiamine HCl 500 mg in sodium chloride injection over a lack of assurance of sterility.
Product
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0310-2026·2026-02-18
Estradiol 15mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 14,848 pellets of ESTRADIOL, 15 mg sterile pellets over the potential presence of metal particulate matter.
Product
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0317-2026·2026-02-18
Testosterone 18mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 146 pellets of Testosterone, 18.0 mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0309-2026·2026-02-18
Estradiol 12.5mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 22,478 pellets of ESTRADIOL, 12.5 mg sterile pellets over the potential presence of metal particulate matter.
Product
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2026·2026-02-18
PowerGlide and central line kits recalled over open swabstick seals
Medline is recalling 7,380 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0320-2026·2026-02-18
Testosterone 50mg pellets recalled over potential metal particulate matter
Asteria Health is recalling 70,959 pellets of Testosterone, 50.0 mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1326-2026·2026-02-18
Anesthesia artline packs recalled over open swabstick applicator seals
Medline is recalling 120 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2026·2026-02-18
Pediatric catheter securement kits recalled over open swabstick seals
Medline is recalling 450 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0327-2026·2026-02-18
Testosterone 75mg and anastrozole pellets recalled over metal particulate matter
Asteria Health is recalling 670 pellets of Testosterone 75mg, Anastrozole 4mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2026·2026-02-18
Suture removal trays recalled over open swabstick applicator seals
Medline is recalling 2,448 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
Product
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0324-2026·2026-02-18
Testosterone 200mg single pellets recalled over potential metal particulate
Asteria Health is recalling 194,336 pellets of Testosterone, 200 mg sterile pellets over the potential presence of metal particulate matter.
Product
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1316-2026·2026-02-18
IQon Spectral CT recalled over rotor fasteners that may be undertorqued
Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.
Product
IQon Spectral CT; Product Code (REF): 728332;
Category
Medical Device
Distribution
Distributed nationwide