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.

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DateProductReasonClassFirm
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.