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Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
May 6, 2026 Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
May 6, 2026 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... Class I Fresenius Kabi USA, LLC
May 6, 2026 LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Potential software anomaly that can cause the pump to report a false battery-health value (typica... Class I Fresenius Kabi USA, LLC
May 6, 2026 Spinal Needle procedure kits: Material Description (Material Number) 24GA.... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
May 6, 2026 Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
May 4, 2026 Pediatric care bed; Product Designation: KayserBett IDA; If the adjustment functions of the hand control, as instructed in the Manual, are not locked with... Class I KAYSERBETTEN GMBH & CO. KG
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 m... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 m... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 m... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
Apr 27, 2026 BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 ... This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... Class I Becton Dickinson & Company
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 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

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.