Browse Device Recalls

203 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 203 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 203 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 6, 2025 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 DELIVERY PACK , Model No SGDV22D-01 SGDV22E ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 DIAGNOSTIC NEURO IR TRAY , Model No WENE21 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LABOR & DELIVERY PACK, Model Nos LLLD19H ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01... ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 4, 2025 CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. During an internal investigation, ACS was unable to confirm that the CODMAN component achieved th... Class II American Contract Systems Inc
Jan 31, 2025 Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Nu... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Aug 7, 2024 Open Shoulder, LWOS39L; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Arthroscopy Pack, MSKA45A; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 ENT, COEN27N; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Endovascular AAA Pack, ESED52B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Day Surgery General Pack, FHGE18T; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Cysto, FTCY03L; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Shoulder, SESH18I; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Endovascular AAA Pack, ESED52B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Cath Lab Pack, CECL02P; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Paracentesis Thoracente, SLPT76H; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Neuro Vascular, ANKV91A; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 PACEMAKER PACK, SLCV01J; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Nasal Sinus Pack, MTSN26B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 IR Procedure Pack, CEAT19W; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Vaginal Delivery, ASDV25B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Hand Pack, AKHD97C; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Pacemaker, COPM11B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
May 15, 2024 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems 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.