State

Pennsylvania product recalls

72,992 recalls have nationwide distribution and so reach Pennsylvania. 11,920 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total: 11,920
Critical: 1,922
Severe: 2,867
Most recent: 2026-09-25

Of the 11,920 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 2,867 (24%) are Severe.

Which agencies issued them

These figures cover only the 11,920 recalls whose distribution notice names Pennsylvania specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7001–7025 of 84912

HighFDA (Devices)·Z-1881-2025·2025-06-04
Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
Product
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1849-2025·2025-06-04
Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion
Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2025·2025-06-04
Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires
Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.
Product
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
Product
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2025·2025-06-04
ELEOS Male-Female Midsection 40MM Orthopedic Component Recall
Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2025·2025-06-04
Segmental Stem Components for ELEOS Limb Salvage System Recalled
Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.
Product
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1860-2025·2025-06-04
DORO Easy-Connect Navigation Adaptor compatibility issue recall
Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.
Product
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2025·2025-06-04
Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue
The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2025·2025-06-04
Cholestech LDX Lipid Profile and Glucose Test Kits Recalled
McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2025·2025-06-04
Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2025·2025-06-04
Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2025·2025-06-04
NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.
Product
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2025·2025-06-04
GM Helix Acqua Implant dental implant size misidentification recall
Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.
Product
GM Helix Acqua Implant, Article Number: 140.985
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2025·2025-06-04
Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion
Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0811-2025·2025-06-04
Mauna Loa Dark Chocolate Covered Macadamias Recalled for Undeclared Nuts
Hawaiian Host Candies is recalling Mauna Loa Dark Chocolate Covered Macadamias due to undeclared almond and cashew. The product label does not list these allergens and may pose a risk to consumers with tree nut allergies.
Product
Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic flexible pouch. Dist. By Mauna Loa Macadamia Nut Corp. Kea au, Hawaii 96749, USA. Label declares Contains: Tree Nuts (Macadamia), Milk and Soy. Each master case contains
Category
Food
Distribution
17 states
HighNHTSA·25V324000·2025-06-04
2025 Nissan Frontier rear display may blank in reverse
The 2025 Nissan Frontier's center information display may show a blank screen in reverse, violating federal rear-visibility standards. This could reduce driver visibility and increase crash risk.
Product
NISSAN — NISSAN FRONTIER, KICKS
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1861-2025·2025-06-04
Straumann Plus Initial Drill missing laser engraving marking
Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.
Product
Plus Initial Drill, Article Number: 103.170;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2025·2025-06-04
Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Product
BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1862-2025·2025-06-04
GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm
Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.
Product
GM Helix Acqua Implant, Article Number: 140.984
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2025·2025-06-04
Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions
Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1821-2025·2025-06-04
Atellica IM Homocysteine Calibrator recalled for assay instability
Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.
Product
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1841-2025·2025-06-04
Abbott Diagnostics Probe Conditioning Solution Recall
Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2025·2025-06-04
Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1843-2025·2025-06-04
Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1828-2025·2025-06-04
BD Microbiology Fluid Thioglycollate Medium Tubes Recall
McKessan Medical-Surgical is recalling BD Microbiology Fluid Thioglycollate Medium tubes due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, potentially resulting in incorrect or delayed test results.
Product
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Category
Medical Device
Distribution
Distributed nationwide