Browse Device Recalls
1,683 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,683 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 1,683 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2026 | OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X ... | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, ... | Class II | Novapproach Spine, LLC |
| Apr 22, 2026 | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 22, 2026 | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... | Class II | Intuitive Surgical, Inc. |
| Apr 22, 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... | Class II | Baxter Healthcare Corporation |
| Apr 22, 2026 | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... | Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... | Class I | Bolton Medical Inc. |
| Apr 22, 2026 | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Class II | BioFire Diagnostics, LLC |
| Apr 21, 2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... | The Adapter for Head Positioning accessory may become loose during patient positioning and uninte... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2026 | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... | Class II | PFM MEDICAL INC. |
| 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 21, 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... | Software in development inadvertently made available for customer use. Use of this software versi... | Class II | GE Medical Systems China Co., Ltd. |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
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.