Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2026 | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 18, 2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... | Class I | Abiomed, Inc. |
| May 15, 2026 | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... | Class I | Medline Industries, LP |
| May 14, 2026 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| 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 8, 2026 | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 6, 2026 | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2)... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: AC... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROO... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| 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 |
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.