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.

2351–2375 of 84837

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-1899-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
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-1850-2026·2026-04-29
Medline Arthroscopy Pack regulatory clearance rescinded
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
Product
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1882-2026·2026-04-29
Medline Polycarbonate Colored Syringes Kits 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 clearance. The recall affects 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2026·2026-04-29
Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2026·2026-04-29
Medline Control Syringes, Guidewires, and High-Pressure Tubing 510(k) Rescinded
Medline Industries has recalled multiple control syringes, guidewires, and high-pressure tubing models because their FDA 510(k) regulatory clearances have been rescinded. The recall affects 38,230 units distributed nationwide.
Product
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2026·2026-04-29
Medline GYN Laparoscopy Pack regulatory clearance rescinded
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
Product
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1901-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
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 (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-1832-2026·2026-04-29
Medline Angio Cath Pack regulatory clearance rescinded nationwide
Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.
Product
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1849-2026·2026-04-29
Medline Medical Device Kits Recall for Loss of 510(k) Clearance
Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.
Product
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ806
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0521-2026·2026-04-29
Claravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
Product
CLARAVIS — CLARAVIS (ISOTRETINOIN)
Category
Drug
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-1905-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
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-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-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
ModerateFDA (Devices)·Z-1897-2026·2026-04-29
nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
Product
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1919-2026·2026-04-29
IV Administration Sets Potential Backflow and Occlusion Risk
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1900-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Category
Medical Device
Distribution
Distributed nationwide
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-1909-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
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