Browse Device Recalls
776 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 776 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 776 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Jun 26, 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short... | Class II | Erbe USA Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tra... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray ... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter ... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ A... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 23, 2026 | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2... | Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility a... | Class II | Arrowhead DE LLC |
| Jun 11, 2026 | Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model... | Due to a defective circuit board that overheats | Class II | Oxos Medical Inc |
| May 21, 2026 | MOSAIQ Oncology Information System | Software may fail to load adapted baseline shift plan during treatment delivery when a communicat... | Class II | Elekta, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Numbe... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Numbe... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 23, 2026 | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33... | Due to stain present on the surface of affected foley catheters. | Class II | C.R. Bard Inc |
| Apr 13, 2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (X... | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | Class II | O&M HALYARD INC |
| Apr 3, 2026 | Brand Name: Geneva Product Name: Brachytherapy Applicator Product Descripti... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Apr 3, 2026 | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Ap... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Apr 3, 2026 | Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavita... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Mar 19, 2026 | Brand Name: Leksell Vantage Arc System REF: 1053958 | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinat... | Class II | Elekta, 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.