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Browse Device Recalls

47 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 47 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 47 FDA device recalls.

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DateProductReasonClassFirm
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 10, 2026 Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Apr 10, 2026 Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... Class I ARROW INTERNATIONAL, LLC
Mar 11, 2026 Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - ... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022... Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PU... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 ... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CAT... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOU... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters R... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II 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.