Recall Register

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Bard Access Systems, Inc.

FDA recalling firm · 10 enforcement events · 41 product records · 2017–2026 · UT

Bard Access Systems, Inc. has 10 FDA enforcement events on this register (41 product records) between 2017 and 2026: 10 device; the busiest year was 2021 with 3.

40% of its events are Class I; the most common class is Class II (6). 5 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
10 Aug 2026Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300; Power-Trialysis Short-Term Curved…DeviceClass I2Ongoing
30 Jul 2026BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NKDeviceClass I1Ongoing
21 May 2026OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal…DeviceClass II14Ongoing
11 Mar 2025BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1,…DeviceClass I1Ongoing
20 Jun 2022Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm…DeviceClass I1Ongoing
19 May 20215 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm GuidewireDeviceClass II1Terminated
19 May 20215Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with MicrointroducerDeviceClass II1Terminated
7 Apr 2021REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.DeviceClass II18Terminated
28 Dec 2017PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.DeviceClass II1Terminated
25 Apr 2017StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.DeviceClass II1Terminated

By type and class

Device10
Class II6
Class I4

Class I: 40% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for Bard Access Systems, Inc. by year initiated.

Questions and answers

How many FDA recalls has Bard Access Systems, Inc. had?

10 enforcement events (41 product records) on this register, 2017–2026: 10 device.

Are any Bard Access Systems, Inc. recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are Bard Access Systems, Inc. recalls?

6 Class II, 4 Class I. 40% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.