State

Pennsylvania product recalls

73,092 recalls have nationwide distribution and so reach Pennsylvania. 11,926 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total: 11,926
Critical: 1,922
Severe: 2,869
Most recent: 2026-09-25

Of the 11,926 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 2,869 (24%) are Severe.

Which agencies issued them

These figures cover only the 11,926 recalls whose distribution notice names Pennsylvania specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8026–8050 of 85018

HighFDA (Devices)·Z-1363-2025·2025-03-26
Medline Proxima sterile surgical drapes recalled due to potential packaging breach
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Product
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2025·2025-03-26
Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2025·2025-03-26
Neuro IR Tray recalled over unconfirmed sterilization assurance
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
Product
NEURO IR TRAY , Model No WENI56J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2025·2025-03-26
Labor and Delivery Pack Recalled Over Unconfirmed Sterilization
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
Product
LABOR & DELIVERY PACK, Model Nos LLLD19H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2025·2025-03-26
Sterile surgical drapes recalled due to potential packaging breach
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
Product
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0283-2025·2025-03-26
Walgreens Acne Cream Recalled for Benzene Contamination
Walgreens Maximum Strength Tinted Acne Treatment Cream is being recalled for benzene contamination. The product was distributed nationwide; affected consumers should stop use immediately.
Product
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2025·2025-03-26
Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
Product
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2025·2025-03-26
CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2025·2025-03-26
Medical Device Sterilization Assurance Recall: MAJOR DIEP Surgical Kits
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
Product
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2025·2025-03-26
Microstream CO2 Intubated Filter Lines Difficult to Disconnect
Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstre
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2025·2025-03-26
Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2025·2025-03-26
Proxima Drape sterile drapes recalled for potential packaging breach risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
Product
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0277-2025·2025-03-26
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2025·2025-03-26
DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0279-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
Product
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0650-2025·2025-03-26
Chef's Line Black Bean Burgers Recalled for Foreign Object
Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.
Product
Chef's Line US Foods, Black Bean Burger, 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen,
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-1332-2025·2025-03-26
DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Product
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2025·2025-03-26
CYSTO Model SACY80R Recall for Sterilization Assurance Failure
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
Product
CYSTO , Model No SACY80R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Product
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2025·2025-03-26
PICC Line Catheters Recalled for Sterilization Assurance Issues
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
Product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0278-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.
Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2025·2025-03-26
CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2025·2025-03-26
Laceration Tray Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0288-2025·2025-03-26
Medline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
Medline Industries has voluntarily recalled over 6.6 million alcohol prep pads nationwide because the product contains less isopropyl alcohol than labeled. The subpotent product was first reported on March 26, 2025.
Product
MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide