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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.