Browse Device Recalls
768 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 768 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 768 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 6, 2026 | Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704... | Urostomy Pouches may leak from cap during use. | Class II | ConvaTec, Inc |
| Jun 30, 2026 | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... | Class II | restor3d Inc. |
| Jun 29, 2026 | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... | Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... | Class II | Contego Medical, Inc |
| Jun 8, 2026 | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | Surgical dressing manufactured out of specification (greater thickness). | Class II | ConvaTec, Inc |
| May 21, 2026 | Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Cl... | Convenience kits contain needle free access device that has an improper seal which may result in... | Class II | Medical Action Industries, Inc. 306 |
| May 13, 2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| May 7, 2026 | Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Co... | Due to out-of-specification, or potential out-of-specification, levels of endotoxins | Class II | TELEFLEX LLC |
| Apr 21, 2026 | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC K... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/A... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 I... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; S... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-L... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/AS... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 1... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 G... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: ACCESS TRAY/ASK-04001-MC3 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI C... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PARACENTESIS KIT/ASK-00376-JHH | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT:... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDUR... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC K... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Mar 17, 2026 | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, R... | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting... | Class I | Medical Action Industries, Inc. 306 |
| Mar 11, 2026 | Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - ... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022... | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PU... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.