Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 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 709 FDA device recalls in CT.

Clear

Date	Product	Reason	Class	Firm
Jul 8, 2016	Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The V...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The V...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The V...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Ite...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The V...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jul 8, 2016	Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: ...	Potential for compromise of the package resulting in a breach of the sterile barrier	Class II	Medtronic
Jun 9, 2016	FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Posit...	If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent...	Class II	Fujifilm Medical Systems U.S.A., Inc.
May 11, 2016	Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 1044480...	Premature bucket failures	Class II	Siemens Healthcare Diagnostics Inc.
May 10, 2016	Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa...	Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Load...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Apr 15, 2016	Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost...	Potential of an allergic reaction in a patient with nickel sensitivity.	Class II	Covidien LLC
Apr 15, 2016	Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic...	Potential of an allergic reaction in a patient with nickel sensitivity.	Class II	Covidien LLC
Apr 1, 2016	Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I...	Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm	Class II	Medtronic
Apr 1, 2016	Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ...	Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm	Class II	Medtronic
Apr 1, 2016	Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU	Reports of failure of the device's power supply.	Class II	Fujifilm Medical Systems U.S.A., Inc.
Mar 24, 2016	Dimension Vista 1500 Intelligent Lab System running on software versions V.3....	Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir...	Class II	Siemens Healthcare Diagnostics Inc.
Mar 24, 2016	Dimension Vista 500 Intelligent Lab System running on software versions V.3.6...	Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir...	Class II	Siemens Healthcare Diagnostics Inc.
Mar 17, 2016	Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cle...	Foreign material in container	Class III	Cygnus Medical
Mar 3, 2016	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 c...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x ...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 6...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 ...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 ...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Sof...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 8...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 4...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x ...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 ...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Mar 3, 2016	Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu...	Compromised sterility due to breach of barrier	Class II	Covidien LLC
Feb 19, 2016	Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routi...	The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers...	Class II	Villa Radiology Systems LLC
Feb 19, 2016	Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of rout...	The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers...	Class II	Villa Radiology Systems LLC
Feb 19, 2016	Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine ra...	The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers...	Class II	Villa Radiology Systems LLC
Feb 19, 2016	Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9...	The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers...	Class II	Villa Radiology Systems LLC
Feb 16, 2016	Milex Arcing Diaphragm Size 95; Model Number: MXWS95	The products have been identified to contain an incorrect size Diaphragm.	Class II	CooperSurgical, Inc.
Jan 22, 2016	Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are u...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Casti...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile so...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soa...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien LLC
Jan 22, 2016	Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap ...	Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con...	Class II	Covidien 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.