Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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Date	Product	Reason	Class	Firm
Mar 31, 2023	ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device	In some cases the communication isolator installed in the Model 52X can cause a disturbance in th...	Class II	J&T Health and Wellness LLC
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 24, 2023	ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC	There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath...	Class I	Cordis US Corp
Mar 23, 2023	WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (s...	The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclo...	Class II	ASO LLC
Feb 28, 2023	Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085	An actuator separated from the pivot mechanism on a lower monitor boom system column and became d...	Class II	Omega Medical Imaging, Inc.
Feb 24, 2023	Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set ...	Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a probl...	Class II	Iradimed Corporation
Feb 21, 2023	PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swa...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, RE...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety o...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 21, 2023	PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825...	Presence of misleading label statements on the product label.	Class II	Entopsis , Inc.
Feb 10, 2023	Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software...	When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may de...	Class II	Sensus Healthcare, Inc.
Dec 20, 2022	RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX	The product may be shorter than packaging indicates	Class II	Bolton Medical Inc.
Dec 20, 2022	RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX	The product may be shorter than packaging indicates	Class II	Bolton Medical Inc.
Dec 7, 2022	Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone i...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMa...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Syste...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ S...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Pediatric Craniotome Ref:CRANI-P-G1	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104JP	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1205	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare Model 1102	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF MCS1705PU	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1103	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare Model 1101	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104CA-CLIN	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare Model 1100	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 18, 2022	BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnost...	Beckman Coulter has become aware of an increase in customer complaints generated for intermittent...	Class II	Beckman Coulter, Inc.
Nov 17, 2022	OttLite Rechargeable UVC Disinfecting Wand	Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exp...	Class II	Ottlite TEchnologies, Inc.
Nov 7, 2022	Cordis Angiographic Catheter Extensions. Used to transport fluid from th...	There is a potential for separation at the male connector.	Class II	Cordis US Corp
Nov 2, 2022	Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-...	The devices may be packaged with the wrong reamer size.	Class II	Arthrex, Inc.

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.