Browse Device Recalls
478 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 478 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 478 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Cod... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 H... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45552 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 455... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Ca... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 450... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45541 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC Kit Product Code: ASK 45541 LVH1 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Cat... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 H... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Cath... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Nov 14, 2018 | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with ... | The lidstock states the incorrect priming volume and flow rates. | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable ... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow Au... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow A... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow Aut... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow A... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Di... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow Aut... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Di... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoF... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International 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.