Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

214 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 214 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 214 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 15, 2022 Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per ca... The extension set has a high probability of failure which could lead to possible leakage or detac... Class II B. Braun Medical, Inc.
Sep 15, 2022 ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 uni... The extension set has a high probability of failure which could lead to possible leakage or deta... Class II B. Braun Medical, Inc.
Sep 15, 2022 CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per c... The extension set has a high probability of potential failure which could lead to possible leakag... Class II B. Braun Medical, Inc.
Jan 31, 2022 Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis... This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for us... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: si... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outloo... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infus... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infus... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with th... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Saf... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with th... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for u... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safet... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Jun 25, 2021 Infusomat Space Volumetric Pump Administration Set, Product Code 490100 There is a potential for the Anti-free flow clip of the administration set to be inverted which m... Class II B. Braun Medical, Inc.
Mar 15, 2021 Filtered Triple-Leg Extension Set - Intravascular administration set. Product... BBMI has identified through complaints the potential for the extension set to become occluded or ... Class II B. Braun Medical, Inc.
Nov 20, 2019 Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Safeline Y-Type Blood Set, Catalog Number NF5140 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Safeline Y-Type Blood Set, Catalog Number V2500 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490314 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490530 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490293 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Nov 20, 2019 Y-Type Blood Set, Catalog Number 490425 Potential for leakage at the joint between the blood filters and tubing Class II B. Braun Medical, Inc.
Jul 10, 2019 ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
Jul 10, 2019 CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186 The filter capacity is not achieved due to damage of the filter membrane. Class II B. Braun Medical, Inc.
May 1, 2019 B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog ... Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint ... Class I B. Braun Medical, Inc.
Jul 20, 2018 CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device us... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection de... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connectio... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device u... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connecti... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device u... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connecti... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, Inc.
Jul 20, 2018 CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used ... The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... Class II B. Braun Medical, 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.