State

Pennsylvania product recalls

72,919 recalls have nationwide distribution and so reach Pennsylvania. 11,918 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total: 11,918
Critical: 1,922
Severe: 2,866
Most recent: 2026-09-09

Of the 11,918 recalls naming Pennsylvania we have scored against our rubric, 1,922 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,866 (24%) are Severe.

Which agencies issued them

These figures cover only the 11,918 recalls whose distribution notice names Pennsylvania specifically. The 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2326–2350 of 84837

HighFDA (Devices)·Z-1894-2026·2026-04-29
LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
Product
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Contro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2026·2026-04-29
Diversatek Healthcare Viper Balloon Dilator catheter inflation tag error
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the catheter inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1938-2026·2026-04-29
Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error
Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.
Product
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1911-2026·2026-04-29
Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
Product
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)25121
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2026·2026-04-29
Arrow Pressure Injectable Central Venous Catheters Recalled
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2026·2026-04-29
Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
Product
OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1895-2026·2026-04-29
LeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.
Product
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Co
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1925-2026·2026-04-29
Flamingo Funnel Medium surgical device recall due to sterilization incompatibility
SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.
Product
Flamingo Funnel Medium, Model Number SQ20012-02
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2026·2026-04-29
Furosemide tablets recalled for presence of N-nitroso impurity
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0667-2026·2026-04-29
Chips Ahoy Baked Bites Brookie recalled over hard corn starch lumps
CHIPS AHOY! Baked Bites Brookie cartons are being recalled because hard corn starch lumps were found in the product. 437 cases are affected.
Product
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-1848-2026·2026-04-29
Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
Product
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2026·2026-04-29
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Product
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1903-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1893-2026·2026-04-29
LeadCare II Blood Lead Test Kit Recall for Inaccurate Results
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.
Product
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1889-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1838-2026·2026-04-29
Medline Heart Transplant Biopsy Kit regulatory clearance rescinded
Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1884-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design
Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1898-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1887-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1921-2026·2026-04-29
IV Administration Sets and Gravity Infusion Kits Risk Backflow
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kits (Part Number AMS14994A) due to a potential for backflow of medication from secondary IV containers into primary IV containers. The recall affects 520 units distributed nationwide.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2026·2026-04-29
Medline Namic Control Syringes recalled due to rescinded FDA clearance
Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 units distributed nationwide.
Product
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1926-2026·2026-04-29
Flamingo Funnel Large surgical smoke evacuation device recall
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Large, Model Number SQ20012-03
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1840-2026·2026-04-29
Medline General Laparoscopy Kit regulatory clearance rescinded
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.
Product
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1829-2026·2026-04-29
Medline Namic Guidewires Recall Due to Rescinded FDA Clearance
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
Product
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115;
Category
Medical Device
Distribution
Distributed nationwide