State

Puerto Rico product recalls

72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

876–900 of 75997

HighFDA (Devices)·Z-2609-2026·2026-07-08
Medline Convenience Kits Containing Recalled Swan-Ganz Catheters
Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-1130-2026·2026-07-08
MorningStar Farms Hot & Spicy Sausage Patties Recalled for Plastic Contamination
Mars Snacking is recalling MorningStar Farms Hot & Spicy Sausage Patties due to potential contamination with plastic material. The recall affects 17,218 cases distributed across 40 U.S. states and Puerto Rico.
Product
MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a resealable plastic bag with UPC 028989100948, packed 6 bags per case
Category
Food
Distribution
41 states
HighFDA (Devices)·Z-2623-2026·2026-07-08
GC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.
Product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0661-2026·2026-07-08
Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0655-2026·2026-07-08
Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.
Product
PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2026·2026-07-08
IntelliCuff Portable Automatic Cuff Pressure Controller Recall
Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.
Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2026·2026-07-08
Boston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall
Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.
Product
CRE Pro Wireguided 12-15mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2618-2026·2026-07-08
Medacta Short Monobloc Stem Broaches Surgical Instruments Shoulder Implant
Medacta USA is recalling Short Monobloc Stem Broaches used in shoulder replacement surgery due to positioning misalignment that may increase risk of fracture in the upper arm bone.
Product
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2026·2026-07-08
CRE Pro Wireguided medical device sterile packaging breach recall
Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been distributed worldwide.
Product
CRE Pro Wireguided 10-12mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2026·2026-07-08
Medline Convenience Kits with Swan-Ganz Catheters Recalled
Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0660-2026·2026-07-08
Amphetamine extended-release capsules contain immediate-release pellets after label mix-up
Mixed amphetamine salts extended-release capsules, 5 mg, from Lannett are being recalled because the capsules contain only immediate-release pellets. 1,392 bottles affected.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2646-2026·2026-07-08
RayCare 2024A SP1 Oncology Information System Software Recall
RayCare 2024A SP1 oncology software may lose data if beam set delivery notes are modified simultaneously or updated during treatment sessions, with users not notified of changes.
Product
RayCare 2024A SP1. Oncology Information Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2639-2026·2026-07-08
Pilling Wecksorb Neurosponges Surgical Sponges Recalled for Endotoxin Contamination
Teleflex LLC is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to out-of-specification or potentially out-of-specification endotoxin levels. The cotton surgical sponges are used in brain and spine surgery.
Product
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2612-2026·2026-07-08
Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, risking infection, medication loss, and blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2026·2026-07-08
Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection
Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.
Product
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2643-2026·2026-07-08
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.
Product
ARTIS icono floor. Model Number: 11327700.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2026·2026-07-08
Terpenicol Antifungal Solution Recalled for CGMP Deviations
Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.
Product
TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2666-2026·2026-07-08
PowerPICC Catheters recalled for deficient manufacturing practices
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Product
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2630-2026·2026-07-08
CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Product
CRE Pro Wireguided 15-18mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2546-2026·2026-07-08
Medline Circumcision Trays recalled due to Lidocaine quality issues
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Product
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0699-2026·2026-07-08
Revitaderm Wound Care Benzalkonium Chloride OTC Drug Recall
Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.
Product
REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2662-2026·2026-07-08
PowerMidline Catheters Recalled for Deficient Manufacturing Practices
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
Product
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2547-2026·2026-07-08
Medline Ophthalmic Pack with Lidocaine Injection Kits Recalled
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.
Product
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2641-2026·2026-07-08
ARTIS icono biplane medical imaging system detector lift malfunction
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
Product
ARTIS icono biplane. Model Number: 11327600.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2539-2026·2026-07-08
Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Category
Medical Device
Distribution
Distributed nationwide