Browse Device Recalls
3,148 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,148 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 3,148 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 6, 2026 | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... | Class I | Spectra Medical Devices, Llc |
| Jun 23, 2026 | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2... | Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility a... | Class II | Arrowhead DE LLC |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 1, 2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF... | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Arterial Line Kit 20ga x 6, REF: 400115A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | General Biospy Tray, REF: GUTS1000 | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| May 21, 2026 | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... | Class II | Karl Storz Endoscopy |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 18, 2026 | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing... | Sterile wound dressing, lacks sterility assurance | Class II | DeRoyal Industries Inc |
| Apr 29, 2026 | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | Class II | Boston Scientific Neuromodulation Corporation |
| 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 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 |
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.